prussian blue

PRUSH-un bloo

Commonly used brand name(s)

In the U.S.

• Radiogardase

Available Dosage Forms:

• Capsule

Therapeutic Class: Pigmentation Agent

Uses For prussian blue

Prussian blue is used to treat thallium poisoning and radiocesium poisoning. It works by combining with thallium and radiocesium in the intestines. The combination is then removed from the body through the stools. By removing the thallium or radiocesium, the medicine lessens damage to your body's organs and tissues.

Prussian blue is available only with your doctor's prescription.

Before Using prussian blue

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For prussian blue, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to prussian blue or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of prussian blue in children with use in other age groups, prussian blue is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of prussian blue in the elderly with use in other age groups, prussian blue is not expected to cause different side effects or problems in older people than it does in younger adults.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of prussian blue. Make sure you tell your doctor if you have any other medical problems, especially:

• Blockage of the intestines or


• Constipation—prussian blue may not work properly if these conditions are present

Proper Use of prussian blue

Keep taking prussian blue for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

If you are unable to swallow the capsule, you may open the capsule and empty the contents into a glass (8 ounces) of warm water. Stir gently until the medicine is mixed with the water. Drink the water with the medicine right away. If there is any medicine left in the bottom of the glass, add a little more warm water to the glass and drink that too.

Your doctor may advise you to take prussian blue with a laxative, such as sorbitol, to help prevent constipation.

Dosing

The dose of prussian blue will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of prussian blue. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  
  • For acute thallium poisoning:
    
    • Adults and children—3 grams taken right away, followed by 3 to 20 grams a day divided into smaller doses as directed by your doctor. Or, the dose may be 3 grams taken right away, followed by 250 milligrams (mg) per kilogram (kg) (113.5 mg per pound) of body weight a day divided into four smaller doses. Either dose may be taken for two to three weeks as determined by your doctor.
    
    
  
  
  • For chronic thallium poisoning:
    
    • Adults and children—The usual dose is 3 to 20 grams a day divided into smaller doses as directed by your doctor. Or, the dose may be 250 mg per kg (113.5 mg per pound) of body weight a day divided into four smaller doses. Either dose may be taken for two to three weeks as determined by your doctor.
    
    
  
  
  • For radiocesium poisoning:
    
    • Adults and children—The usual dose is 500 mg every two hours, for a total dose of 3000 mg (3 grams) a day. This dose may be taken for as little as several days or as long as three weeks, as determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of prussian blue, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

prussian blue Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Constipation

prussian blue commonly causes unusually dark stools. This side effect does not usually need medical attention.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More prussian blue resources

• Prussian blue Support Group
• 0 Reviews for Prussian blue - Add your own review/rating

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• Prussian Blue Professional Patient Advice (Wolters Kluwer)


• Prussian blue Concise Consumer Information (Cerner Multum)

Compare prussian blue with other medications

• Radiation Emergency

Tramadol 50mg / ml Solution for Injection or Infusion

1. Name Of The Medicinal Product

Tramadol 50mg/ml Solution for Injection or Infusion.

2. Qualitative And Quantitative Composition

Each ampoule contains 100mg tramadol hydrochloride in 2ml solution (50mg/ml).

For a full list of excipients see Section 6.1.

3. Pharmaceutical Form

Solution for Injection or Infusion

A clear colourless solution in glass ampoules.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment and prevention of moderate to severe pain.

4.2 Posology And Method Of Administration

As with all analgesic drugs, the dose of tramadol should be adjusted according to the severity of pain and the clinical response of the patient. The tramadol solution is for parenteral injection either intramuscularly, by slow intravenous injection or diluted in solution (see Section 6.6 Special instructions for use and handling) for administration by infusion or patient controlled analgesia.

Adults and children 12 years and over:

The usual dose is 50mg or 100mg 4 to 6 hourly by either intramuscular or intravenous routes. Intravenous injections must be given slowly over 2–3 minutes. The dose should be adjusted according to the severity of the pain and the response.

For post-operative pain, an initial bolus of 100mg is administered. During the 60 minutes following the initial bolus, further doses of 50mg may be given every 10-20 minutes, up to a total dose of 250mg including the initial bolus. Subsequent doses should be 50mg or 100mg 4-6 hourly up to a total daily dose of 600mg.

Elderly:

The usual dosages may be used. However, it is reported that in volunteers aged over 75 years, the elimination half-life of tramadol was increased by 17% following oral administration.

Renal impairment/renal dialysis:

The elimination of tramadol may be prolonged. The usual adult dosage may be used but the dosage interval should be adjusted. For patients with creatinine clearance <30ml/min, the dosage interval should be increased to 12 hours. For patients with severe renal impairment (creatinine clearance of <10ml/min) tramadol is not recommended. As tramadol is only removed slowly by haemodialysis or haemofiltration, post-dialysis administration to maintain analgesia is not usually necessary.

Hepatic impairment:

The elimination of tramadol may be prolonged by hepatic impairment. The usual initial dosage should be used but, in cases of severe hepatic impairment, the dosage interval should be increased to 12 hours.

Children under 12 years:

Not recommended.

4.3 Contraindications

Tramadol 50mg/ml Solution for Injection should not be given to patients who have previously demonstrated hypersensitivity towards tramadol or any of the other ingredients (see Section 6.1 for 'list of excipients'). Tramadol 50mg/ml Solution for injection should not be given to patients suffering from acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.

In common with other opioid analgesics, tramadol should not be administered to patients who are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal (see section 4.5 'Interaction with other medicinal products and other forms of interaction').

4.4 Special Warnings And Precautions For Use

Warnings

At therapeutic doses, tramadol has the potential to cause withdrawal symptoms. Rarely, cases of dependence and abuse have been reported.

At therapeutic doses withdrawal symptoms have been reported at a frequency of 1 in 8,000. Reports of dependence and abuse have been less frequent. Because of this potential the clinical need for continued analgesic treatment should be reviewed regularly.

In patients with a tendency to drug abuse or dependence, treatment should be for short periods and under strict medical supervision.

Tramadol 50mg/ml Solution for Injection is not a suitable substitute in opioid dependent patients. The product does not suppress morphine withdrawal symptoms although it is an opioid agonist.

Tramadol 50mg/ml Solution for Injection may cause drowsiness and this effect may be potentiated by alcohol and other CNS depressants. Ambulant patients should be warned not to drive or operate machinery if affected (see section 4.7 Effects on the ability to drive and use machines)

Precautions

Tramadol 50mg/ml Solution for Injection should be used with caution in patients with head injury, increased intracranial pressure, severe impairment of hepatic and renal function and in patients prone to convulsive disorders or in shock.

Convulsions have been reported at therapeutic doses and the risk may be increased at doses exceeding the usual upper daily dose limit. Patients with a history of epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling reasons. The risk of convulsions may increase in patients taking tramadol and concomitant medication that can lower the seizure threshold (see section 4.5 'Interactions with other Medicinal Products and other Forms of Interactions').

Care should be taken when treating patients with respiratory depression, or if concomitant CNS depressant drugs are being administered, as the possibility of respiratory depression cannot be excluded in these situations. At therapeutic doses respiratory depression has infrequently been reported. In one study using a nitrous oxide/opioid (tramadol) anaesthetic technique (with only intermittent administration of enflurane 'as required') tramadol was reported to enhance intra-operative recall. Hence its use during potentially very light planes of general anaesthesia should be avoided.

Two studies of tramadol administration during anaesthesia comprising continuous administration of isoflurane have shown clinically significant lightening of anaesthetic depth or intra-operative recall. Therefore providing the current practice of administering continuous, potent (volatile or intravenous) anaesthetic agent is followed, tramadol may be used intra-operatively in the same way as other analgesic agents are routinely used.

This medicinal product contains approximately 8.29mg sodium acetate trihydrate (1.4mg sodium) per 2ml dose.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Tramadol 50mg/ml Solution for Injection should not be combined with MAO inhibitors (see Section 4.3 'Contraindications').

Concomitant administration of Tramadol 50mg/ml Solution for Injection with other centrally acting drugs, including alcohol, may potentiate CNS depressant effects (see Section 4.8 'Undesirable Effects').

Tramadol may increase the potential for both selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants (TCAs) to cause convulsions (see Section 4.4 'Special Warnings and Precautions for Use' and 5.2 'Pharmacokinetic Properties').

Theoretically there is a possibility that tramadol could interact with lithium. There have been no reports of this potential interaction.

Serotonergic drugs: Co-administration with serotonergic drugs, e.g. SSRIs or triptans, may lead to an increase of serotonin-associated effects, which can include serotonin syndrome.

There have been isolated reports of interaction with coumarin anticoagulants resulting in an increased INR and so care should be taken when commencing treatment with tramadol in patients on anticoagulants.

Pharmacokinetic studies were conducted to investigate the effects of cimetidine, quinidine and carbamazepine on the pharmacokinetics of tramadol.

Carbamazepine - The simultaneous administration of carbamazepine markedly decreases serum concentrations of tramadol to an extent that a decrease in analgesic effectiveness and a shorter duration of action may occur.

Cimetidine - With the concomitant or previous administration of cimetidine clinically relevant interactions are unlikely to occur. Therefore no alteration of the tramadol dosage regimen is recommended for patients receiving chronic cimetidine therapy.

Quinidine - A study in 12 healthy volunteers has shown that quinidine causes an approximate 25% increase in the tramadol C_max and AUC; T_max is unaffected. However, the increases in C_max and AUC fall within the normal therapeutic range for tramadol, and no dosage adjustment is required.

4.6 Pregnancy And Lactation

Pregnancy

Animal studies with tramadol at very high doses have revealed effects on organ development, ossification and neonatal mortality. Tramadol crosses the placenta. There is inadequate evidence available on the safety of tramadol in human pregnancy, therefore Tramadol 50mg/ml Solution for Injection should not be used in pregnant women.

Lactation

Tramadol and its metabolites are found in small amounts in human breast milk. An infant could ingest 0.1% of the dose given to the mother. Tramadol 50mg/ml Solution for Injection should not be administered during breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

Tramadol 50mg/ml Solution for Injection may cause drowsiness and this effect may be potentiated by alcohol and other CNS depressants. Ambulant patients should be warned not to drive or operate machinery if affected.

4.8 Undesirable Effects

Rapid intravenous administration may be associated with a higher incidence of adverse effects and therefore should be avoided. The most commonly reported adverse drug reactions are nausea and dizziness, both occurring in more than 10 % of patients.

Cardiovascular system disorders: Uncommon (< 1 %) cardiovascular regulation (palpitation, tachycardia, postural hypotension or cardiovascular collapse). These adverse effects may occur especially after intravenous administration and in patients who are physically stressed. Rarely (< 0.1%) bradycardia, increase in blood pressure.

Central and peripheral nervous system disorders: Common (1-10 %) headache, muzziness. Rarely (< 0.1 %) changes in appetite, paraesthesia, tremor, respiratory depression, epileptiform convulsions.

Psychiatric disorders: Rarely (< 0.1 %) hallucinations, confusion, sleep disturbance and nightmares. Psychic side effects may occur following administration of tramadol, which vary individually in intensity and nature (depending on personality and duration of medication). These include changes in mood (usually elation, occasionally dysphoria), changes in activity (usually suppression, occasionally increase) and changes in cognitive and sensorial ability (e.g. decision behaviour, perception disorders). Dependence may occur.

Vision disorders: Rarely (< 0.1%) blurred vision

Respiratory system disorders: Worsening of asthma has been reported, though a causal relationship has not been established.

Gastrointestinal disorders: Very common (>10 %) nausea. Common (1-10%): vomiting, constipation, diarrhoea, dry mouth. Uncommon (< 1 %): retching, gastrointestinal irritation (a feeling of pressure in the stomach, bloating).

Skin and appendages disorders: Common (1-10 %) sweating. Uncommon (< 1 %) dermal reactions (e.g. pruritus, rash, urticaria).

Musculo-Skeletal system disorders: Rarely (< 0.1%) muscle weakness.

Liver and biliary system disorders: In rare cases, increases in liver enzyme values have been reported in a temporal connection with the therapeutic use of tramadol.

Urinary system disorders: Rarely (< 0.1 %) micturition disorders (difficulty in passing urine and urinary retention)

Body as a whole: Rarely (< 0.1 %) allergic reactions (e.g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis. Symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal, may occur as follows: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms.

4.9 Overdose

Symptoms of overdosage are typical of other opioid analgesics, and include miosis, vomiting, cardiovascular collapse, sedation and coma, seizures and respiratory depression.

Supportive measures such as maintaining the patency of the airway and maintaining cardiovascular function should be instituted; naloxone should be used to reverse respiratory depression; fits can be controlled with diazepam.

Tramadol is minimally eliminated from the serum by haemodialysis or haemofiltration. Therefore treatment of acute tramadol intoxication with haemodialysis or haemofiltration alone is not suitable for detoxification.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC code N 02A X02: Analgesics – other opioids

Tramadol 50mg/ml Solution for Injection is a centrally acting analgesic. It is a non-selective pure agonist at mu, delta and kappa opioid receptors with a higher affinity for the mu receptor. Other mechanisms, which may contribute to its analgesic effect, are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release.

5.2 Pharmacokinetic Properties

After oral administration, tramadol is almost completely absorbed. Mean absolute bioavailability is approximately 70% following a single dose and increases to approximately 90% at steady state. Plasma protein binding of tramadol is approximately 20%. When ¹⁴C-labelled tramadol was administered to humans, approximately 90% was excreted via the kidneys with the remaining 10% appearing in the faeces.

Tramadol has a linear pharmacokinetic profile within the therapeutic dosage range. The half-life of the terminal elimination phase (t½β) was 6.0 + 1.5h in young volunteers. Tramadol pharmacokinetics show little age dependence in volunteers up to the age of 75 years. In volunteers aged over 75 years, t½β was 7.0 + 1.6h on oral administration.

Tramadol is metabolised by the cytochrome P450 isoenzyme CYP2D6. It undergoes biotransformation to a number of metabolites mainly by means of N- and O-demethylation. O-desmethyl tramadol appears to be the most pharmacologically active metabolite, showing analgesic activity in rodents. As humans excrete a higher percentage of unchanged tramadol than animals it is believed that the contribution made by this metabolite to analgesic activity is likely to be less in humans than animals. In humans the plasma concentration of this metabolite is about 25% that of unchanged tramadol.

Since tramadol is eliminated both metabolically and renally, the terminal half-life t½β may be prolonged in impaired hepatic or renal function. In patients with liver cirrhosis t½β tramadol was a mean of 13.3 + 4.9h; in patients with renal insufficiency (creatinine clearance < 5 ml/min) it was 11.0 + 3.2h.

The inhibition of one or both cytochrome P450 isoenzymes, CYP3A4 and CYP 2D6, involved in the metabolism of tramadol may affect the plasma concentrations of tramadol or its active metabolite. The clinical consequences of any such interactions are unknown.

5.3 Preclinical Safety Data

In single and repeat-dose toxicity studies (rodents and dogs) exposure to tramadol 10 times that expected in man is required before toxicity (hepatotoxicity) is observed.

Symptoms of toxicity are typical of opioids and include restlessness, ataxia, vomiting, tremor, dyspnoea and convulsions. Exposure to tramadol (

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium acetate trihydrate. Water for injections

6.2 Incompatibilities

Precipitation will occur if Tramadol 50mg/ml Solution for Injection is mixed in the same syringe with injections of diazepam, diclofenac sodium, indometacin, midazolam and piroxicam.

Tramadol 50mg/ml Solution for Injection must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf Life

3 years. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2 to 8°C, unless reconstitution / dilution has taken place in controlled and validated aseptic conditions.

6.4 Special Precautions For Storage

Keep ampoule in the outer carton.

6.5 Nature And Contents Of Container

2ml neutral glass type I glass ampoules. Box of 5 ampoules.

6.6 Special Precautions For Disposal And Other Handling

The prepared infusion solution should be made up immediately before use. Tramadol 50mg/ml Solution for Injection is physically and chemically compatible for up to 24 hours with 4.2% sodium bicarbonate and Ringer's solution.

Or up to 5 days with the following infusion solutions: 0.9% sodium chloride; 0.18% sodium chloride and 4% glucose; sodium lactate compound; or 5% glucose.

ADMINISTRATIVE DATA

7. Marketing Authorisation Holder

Beacon Pharmaceuticals Ltd., Tunbridge Wells, TN1 1YG, UK

8. Marketing Authorisation Number(S)

PL 18157/0014

9. Date Of First Authorisation/Renewal Of The Authorisation

August 2007

10. Date Of Revision Of The Text

Concept DHA

Generic Name: vitamin, mineral, omega-3 supplement

Dosage Form: capsule, liquid filled
see all prescribing information for Concept DHA

DESCRIPTION: Each capsule contains: Ferrous Fumarate (Elemental Iron) . . . . . . . . . . 17.5 mg PolysaccharideIronComplex(ElementalIron).. 17.5mg

(Equivalent to about 35 mg of elemental iron) Vitamin C (from ProAscorb C‡)    .    .    .    .    .    .    .    .    .    .    .    .    25 mg FolicAcid.............................. 1mg ThiamineMononitrate(B1) ................ 2mg Riboflavin(B2) .......................... 3mg Niacin (B3, from ProAscorb C‡)    .    .    .    .    .    .    .    .    .    .    .    .    1.8 mg d-CalciumPantothenate(B5)................ 5mg PyridoxineHCI(B6) .................... 25mg Biotin (B7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300 mcg Cyanocobalamin(B12) ................ 12.5mcg Copper(asCopperSulfate).................. 2mg

Magnesium(asMagnesiumSulfate) . . . . . . . . Zinc(asZincSulfate).................... Omega-3 Fatty Acids .    .    .    .    .    .    .    .    . ...........

(Derived from 310 mg Fish Oil) Docosahexaenoic Acid (DHA) . ........... Eicosapentaenoic Acid (EPA)    . ........... . 5mg 10mg 200 mg156 mg 39 mg

Clinical Studies: Because Ferrous Fumarate is an organic complex, it contains no free ions, either ferric or ferrous. Polysaccharide Iron Complex is clinically non-toxic. Prior studies in rats demonstrated that Polysaccharide Iron Complex (PIC), administered as a single oral dose to Sprague Dawley rats did not produce evidence of toxicity at a dosage level of 5000 mg Iron/kg: (An Acute Oral Toxicity Study in Rats with Polysaccharide-Iron Complex. T.N.Merriman, M. Aikman and R.E. Rush, Springborn Laboratories, Inc. Spencerville, Ohio Study No. 3340.1 March - April 1994). Other clinical studies had demonstrated that Polysaccharide Iron gives a good hematopoietic response with an almost complete absence of the side effects usually associated with oral iron therapy. Picinni and Ricciotti suggested in 1982, that "the therapeutic effectiveness of Polysaccharide Iron Complex when compared with iron fumarate in the treatment of iron deficiency anemia, appears to be as active as the iron fumarate and as well tolerated, however, it exerted a greater influence on the level of hemoglobin and on the number of red cells..." and that, "it has been exceptionally well tolerated by all patients" (Picinni, L.-Ricciotti, M. 1982. Therapeutic effectiveness of an iron-polysaccharide complex in comparison with iron fumarate in the treatment of iron deficiency anemias):    PANMINERVA MEDICA-EUROPA MEDICA, Vol. 24, No. 3, pp. 213-220 (July - September 1982). As mentioned above, the patented source of iron used in Concept DHATM (Ferrous Fumarate and Polysaccharide Iron Complex) provides a high level of elemental iron with a low incidence of gastric distress.

CONCLUSION: Based on the results of this study, the oral combination of Ferrous Fumarate and Polysaccharide Iron Complex was better tolerated and safer than the oral administration of Ferrous Fumarate alone. The conclusion of this research stated, that the addition of PIC to Ferrous Fumarate surprisingly allows the same concentration of Ferrous Fumarate to be better tolerated than the Ferrous Fumarate alone.

INDICATIONS: Concept DHATM is a prescription prenatal vitamin-mineral preparation containing omega-3 fatty acid supplements designed to supply nutritional supplementation for women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Concept DHATM may also be used to improve the nutritional status of women before conception.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. WARNING: Ingestion of more than 3 grams of omega-3 fatty acids from fish oils per day may have potential antithrombotic effects, including an increased bleeding time and INR (international normalized ratio). DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.

WARNING: Folic acid alone is improper therapy in the treatment for pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

PRECAUTIONS: General: Folic acid in doses above 0.1 mg - 0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive.

DOSAGE AND ADMINISTRATION: Adults (persons over 12 years of age), one (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.

HOW SUPPLIED: Concept DHATM are persimmon colored capsules imprinted "US" logo and "Concept DHA" in white. Child resistant bottles of 30 capsules NDC# 52747-621-30. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Store at controlled room temperature 15 ̊ to 30 ̊C (59 ̊ to 86 ̊ F). Keep in a cool, dry place. Capsules are not USP.

Concept DHA  vitamin- mineral omega-3 supplement  capsule, liquid filled

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52747-621 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS FUMARATE (IRON) FERROUS FUMARATE 53.5 mg IRON (IRON) IRON 38 mg ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 25 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg THIAMINE MONONITRATE (THIAMINE ) THIAMINE MONONITRATE 2 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg NIACIN (NIACIN) NIACIN 1.8 mg CALCIUM PANTOTHENATE (CALCIUM PANTOTHENATE) CALCIUM PANTOTHENATE 5 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg BIOTIN (BIOTIN) BIOTIN 300 ug CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12.5 ug CUPRIC SULFATE (COPPER) COPPER 2 mg MAGNESIUM SULFATE (MANGANESE) MANGANESE 5 mg ZINC SULFATE (ZINC) ZINC 10 mg OMEGA-3-ACID ETHYL ESTERS (OMEGA-3-ACID ETHYL ESTERS) OMEGA-3-ACID ETHYL ESTERS 200 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color pink (pink) Score score with uneven pieces Shape CAPSULE Size 22mm Flavor Imprint Code Concept;DHA;US Contains

Packaging # NDC Package Description Multilevel Packaging 1 52747-621-30 30 CAPSULE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/24/2009

Labeler - US Pharmaceutical Corporation (048318224)

Revised: 12/2009US Pharmaceutical Corporation

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• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Trexall

Generic Name: methotrexate (Oral route, Injection route)

meth-oh-TREX-ate

Injection route(Powder for Solution;Solution)

Only for life-threatening neoplastic disease or severe rheumatoid arthritis and psoriasis unresponsive to other therapies. Death, fetal death and/or congenital anomalies, lung disease, tumor lysis syndrome, fatal skin reactions, and Pneumocystis carinii pneumonia have been reported. Monitor for bone marrow, liver, lung, and kidney toxicities. Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs). Hepatotoxicity, fibrosis, and cirrhosis occur with prolonged use. Diarrhea and ulcerative stomatitis require interruption of therapy. Methotrexate elimination is reduced in patients with impaired renal functions, ascites, or pleural effusions. Increased risk of soft tissue necrosis and osteosarcoma with concomitant radiotherapy. Malignant lymphoma may occur. Use extreme caution with high dose regimen for osteosarcoma. Do not use formulations/diluents with preservatives for intrathecal or high dose therapy .

Oral route(Tablet)

Only for life-threatening neoplastic disease or severe rheumatoid arthritis and psoriasis unresponsive to other therapies. Death, fetal death and/or congenital anomalies, lung disease, tumor lysis syndrome, fatal skin reactions, and Pneumocystis carinii pneumonia have been reported. Monitor for bone marrow, liver, lung, and kidney toxicities. Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs). Hepatotoxicity, fibrosis, and cirrhosis occur with prolonged use. Diarrhea and ulcerative stomatitis require interruption of therapy. Methotrexate elimination is reduced in patients with impaired renal functions, ascites, or pleural effusions. Increased risk of soft tissue necrosis and osteosarcoma with concomitant radiotherapy. Malignant lymphoma may occur .

Commonly used brand name(s)

In the U.S.

• Rheumatrex Dose Pack


• Trexall

Available Dosage Forms:

• Tablet


• Solution


• Powder for Solution


• Injectable

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Antimetabolite

Uses For Trexall

Methotrexate belongs to the group of medicines known as antimetabolites. It is used to treat cancer of the breast, head and neck, lung, blood, bone, and lymph, and tumors in the uterus. It may also be used to treat other kinds of cancer, as determined by your doctor.

Methotrexate blocks an enzyme needed by the cell to live. This interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by methotrexate, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with methotrexate, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Methotrexate is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, methotrexate is used in certain patients with the following medical conditions:

• Acute nonlymphocytic leukemia (a type of cancer of the blood and lymph system)


• Cancer in the membranes that cover and protect the brain and spinal cord (the meninges)


• Cancer of the bladder


• Cancer of the brain (lymphoma)


• Cancer of the cervix


• Cancer of colon and rectum


• Cancer of the esophagus


• Cancer of the ovaries


• Cancer of the pancreas


• Cancer of the penis


• Cancers of the soft tissues of the body, including the muscles, connective tissues (tendons), vessels that carry blood or lymph, or fat


• Cancer of the stomach


• Hodgkin's lymphoma (a cancer of the lymph system, a part of the body's immune system)

Before Using Trexall

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Newborns and other infants may be more sensitive to the effects of methotrexate. However, in other children it is not expected to cause different side effects or problems than it does in adults.

Geriatric

Side effects may be more likely to occur in the elderly, who are usually more sensitive to the effects of methotrexate.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Alclofenac


• Amoxicillin


• Apazone


• Asparaginase


• Aspirin


• Bacillus of Calmette and Guerin Vaccine, Live


• Benoxaprofen


• Bentiromide


• Bismuth Subsalicylate


• Carprofen


• Dantrolene


• Dexlansoprazole


• Diclofenac


• Diflunisal


• Dipyrone


• Doxycycline


• Droxicam


• Esomeprazole


• Etodolac


• Fenbufen


• Fenoprofen


• Flurbiprofen


• Ibuprofen


• Indomethacin


• Indoprofen


• Influenza Virus Vaccine, Live


• Isoxicam


• Ketoprofen


• Ketorolac


• Leflunomide


• Measles Virus Vaccine, Live


• Meclofenamate


• Mefenamic Acid


• Mezlocillin


• Mumps Virus Vaccine, Live


• Nabumetone


• Naproxen


• Nimesulide


• Omeprazole


• Oxaprozin


• Pantoprazole


• Penicillin G


• Penicillin V


• Phenylbutazone


• Phenytoin


• Piperacillin


• Pirazolac


• Piroxicam


• Pirprofen


• Pristinamycin


• Probenecid


• Proquazone


• Pyrimethamine


• Rabeprazole


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Salsalate


• Smallpox Vaccine


• Sulfamethizole


• Sulfamethoxazole


• Sulfapyridine


• Sulfisoxazole


• Sulindac


• Suprofen


• Tamoxifen


• Tenidap


• Tenoxicam


• Tiaprofenic Acid


• Tolmetin


• Triamterene


• Trimethoprim


• Typhoid Vaccine


• Varicella Virus Vaccine


• Warfarin


• Yellow Fever Vaccine


• Zomepirac

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone


• Cyclosporine


• Eltrombopag


• Mercaptopurine


• Procarbazine


• Rofecoxib


• Theophylline

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of)—Increased risk of unwanted effects on the liver

• Chickenpox (including recent exposure) or


• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Colitis

• Disease of the immune system

• Gout (history of) or


• Kidney stones (or history of)—Methotrexate may increase levels of a chemical called uric acid in the body, which can cause gout or kidney stones

• Infection—Methotrexate can reduce immunity to infection

• Intestine blockage or


• Kidney disease or


• Liver disease—Effects may be increased because of slower removal of methotrexate from the body

• Mouth sores or inflammation or


• Stomach ulcer—May be worsened

Proper Use of methotrexate

This section provides information on the proper use of a number of products that contain methotrexate. It may not be specific to Trexall. Please read with care.

Take this medicine only as directed by your doctor. Do not take more or less of it, and do not take it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

Methotrexate is often given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

While you are using methotrexate, your doctor may want you to drink extra fluids so that you will pass more urine. This will help the drug to pass from the body, and will prevent kidney problems and keep your kidneys working well.

Methotrexate commonly causes nausea and vomiting. Even if you begin to feel ill, do not stop using this medicine without first checking with your doctor. Ask your health care professional for ways to lessen these effects.

If you vomit shortly after taking a dose of methotrexate, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Trexall

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Do not drink alcohol while using this medicine. Alcohol can increase the chance of liver problems.

Some patients who take methotrexate may become more sensitive to sunlight than they are normally. When you first begin taking methotrexate, avoid too much sun and do not use a sunlamp until you see how you react to the sun, especially if you tend to burn easily. In case of a severe burn, check with your doctor.

Do not take medicine for inflammation or pain (aspirin or other salicylates, diclofenac, diflunisal, fenoprofen, ibuprofen, indomethacin, ketoprofen, meclofenamate, mefenamic acid, naproxen, phenylbutazone, piroxicam, sulindac, suprofen, tolmetin) without first checking with your doctor. These medicines may increase the effects of methotrexate, which could be harmful.

While you are being treated with methotrexate, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Methotrexate may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Methotrexate can lower the number of white blood cells in your blood temporarily, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

Trexall Side Effects

Along with their needed effects, medicines like methotrexate can sometimes cause unwanted effects such as blood problems, kidney problems, stomach or liver problems, loss of hair, and other side effects. These and others are described below. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Black, tarry stools


• blood in urine or stools


• bloody vomit


• diarrhea


• joint pain


• reddening of skin


• stomach pain


• swelling of feet or lower legs

Less common

• Blurred vision


• confusion


• convulsions (seizures)


• cough


• pinpoint red spots on skin


• shortness of breath


• unusual bleeding or bruising

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Sores in mouth and on lips

Less common

• Back pain


• cough or hoarseness accompanied by fever or chills


• dark urine


• dizziness


• drowsiness


• fever or chills


• headache


• lower back or side pain accompanied by fever or chills


• painful or difficult urination accompanied by fever or chills


• unusual tiredness or weakness


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Loss of appetite


• nausea or vomiting

Less common

• Acne


• boils


• pale skin


• skin rash or itching

This medicine may cause a temporary loss of hair in some people. After treatment with methotrexate has ended, normal hair growth should return.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Back pain


• blurred vision


• confusion


• convulsions (seizures)


• dizziness


• drowsiness


• fever


• headache


• unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Trexall side effects (in more detail)

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More Trexall resources

• Trexall Side Effects (in more detail)
• Trexall Use in Pregnancy & Breastfeeding
• Drug Images
• Trexall Drug Interactions
• Trexall Support Group
• 0 Reviews for Trexall - Add your own review/rating

• Trexall Prescribing Information (FDA)


• Trexall MedFacts Consumer Leaflet (Wolters Kluwer)


• Trexall Concise Consumer Information (Cerner Multum)


• Methotrexate Prescribing Information (FDA)


• Methotrexate Monograph (AHFS DI)


• Methotrexate MedFacts Consumer Leaflet (Wolters Kluwer)


• Methotrexate Sodium, Preservative Free injection Concise Consumer Information (Cerner Multum)

Compare Trexall with other medications

• Acute Lymphoblastic Leukemia
• Acute Lymphocytic Leukemia
• Acute Nonlymphocytic Leukemia
• Bladder Cancer
• Brain Tumor
• Breast Cancer
• Bullous Pemphigoid
• Cervical Cancer
• Choriocarcinoma
• Cogan's Syndrome
• Colorectal Cancer
• Dermatomyositis
• Ectopic Pregnancy
• Eczema
• Esophageal Carcinoma
• Gastric Cancer
• Graft-versus-host disease
• Head and Neck Cancer
• Hodgkin's Lymphoma
• Lymphoma
• Meningeal Leukemia
• Mycosis Fungoides
• Neoplastic Diseases
• Non-Hodgkin's Lymphoma
• Non-Small Cell Lung Cancer
• Osteosarcoma
• Ovarian Cancer
• Pancreatic Cancer
• Pemphigoid
• Pemphigus
• Psoriasis
• Psoriatic Arthritis
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• Small Cell Lung Cancer
• Soft Tissue Sarcoma
• Solid Tumors
• Systemic Sclerosis
• Trophoblastic Disease
• Uveitis

ferumoxsil

Generic Name: ferumoxsil (fer yoo MOX il)

Brand Names: GastroMARK

What is ferumoxsil?

Ferumoxsil is in a group of drugs called imaging contrast agents. Ferumoxsil contains iron, a substance that is magnetic. Contrast agents are used to allow certain internal organs to be seen clearly on an MRI (magnetic resonance imaging).

Ferumoxsil is used to help diagnose certain disorders of the stomach or intestines.

Ferumoxsil may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about ferumoxsil?

Do not receive this medication if you are allergic to ferumoxsil, or if you have a blocked or perforated intestine.

Before receiving this medication, tell your doctor if you are allergic to any drugs, if you have an iron overload disorder (such as chronic hemolytic anemia) or if you have received frequent blood transfusions. Also tell your doctor if you have a history of hiatal hernia, gastroesophageal reflux disease (GERD), inflammatory bowel disease, or if you have recently had any nausea, vomiting or diarrhea.

After receiving ferumoxsil, call your doctor at once if you have severe stomach pain or cramping, or a skin rash with bruising, severe tingling, numbness, pain, and muscle weakness.

Less serious side effects are more likely to occur, such as mild stomach pain, nausea, vomiting, diarrhea, headache, or numbness and tingling of your mouth.

What should I discuss with my health care provider before receiving ferumoxsil?

Do not receive this medication if you are allergic to ferumoxsil, or if you have a blocked or perforated intestine.

Before receiving this medication, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  an iron overload disorder such as chronic hemolytic anemia;

  
  


• 
  

  a history of frequent blood transfusions;

  
  


• 
  

  a history of hiatal hernia;

  
  


• 
  

  gastroesophageal reflux disease (GERD);

  
  


• 
  

  inflammatory bowel disease;

  
  


• 
  

  if you tend to burp up food, especially when lying down after a meal; or

  
  


• 
  

  if you have recently had any nausea, vomiting, or diarrhea.

  
  

If you have any of these conditions, you may not be able to receive ferumoxsil.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether ferumoxsil passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is ferumoxsil used?

Ferumoxsil is a liquid that you will be asked to drink before your MRI is performed.

Ferumoxsil must be taken on an empty stomach. You will need to fast (not eat or drink anything) for at least 4 hours before you take this medicine.

In some cases, the MRI will be done within 30 minutes after you drink the ferumoxsil. However, you may be asked to drink the liquid several hours before your MRI. Follow your doctor's instructions.

What happens if I miss a dose?

Since ferumoxsil is used only for the purposes of your MRI, you will not be on a dosing schedule.

What happens if I overdose?

Contact your doctor if you think you have received too much of this medication. Symptoms of a ferumoxsil overdose are not known.

What should I avoid while taking ferumoxsil?

On the day of your MRI, avoid foods or beverages that upset your stomach. Ferumoxsil can cause mild to severe stomach discomfort.

Ferumoxsil side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  severe stomach pain or cramping; or

  
  


• 
  

  skin rash, bruising, severe tingling, numbness, pain, muscle weakness.

  
  

Less serious side effects are more likely to occur, such as:

• 
  

  mild stomach pain, nausea, vomiting, diarrhea;

  
  


• 
  

  upset stomach;

  
  


• 
  

  skin rash or itching;

  
  


• 
  

  headache; or

  
  


• 
  

  numbness or tingling in or around your mouth.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ferumoxsil?

Before receiving this medication, tell your doctor if you are using iron supplements.

There may be other drugs that can affect ferumoxsil. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More ferumoxsil resources

• Ferumoxsil Drug Interactions
• Ferumoxsil Support Group
• 0 Reviews for Ferumoxsil - Add your own review/rating

• Gastromark Prescribing Information (FDA)

Compare ferumoxsil with other medications

• Diagnosis and Investigation

Where can I get more information?

• Your doctor has information about ferumoxsil written for health professionals that you may read.

Solpadol Capsules

1. Name Of The Medicinal Product

Solpadol Capsules

2. Qualitative And Quantitative Composition

Active Constituents
Paracetamol	500.0mg
Codeine Phosphate Hemihydrate	30.0mg

For excipients see 6.1.

3. Pharmaceutical Form

Capsules.

Solpadol Capsules are grey and purple with SOLPADOL printed on them in black ink.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of severe pain.

4.2 Posology And Method Of Administration

Adults:	Two capsules not more frequently than every 4 hours, up to a maximum of 8 capsules in any 24 hour period.
Elderly:	As for adults, however a reduced dose may be required. See warnings.
Children:	Not recommended for children under 12 years of age.

Solpadol capsules are for oral administration.

4.3 Contraindications

Hypersensitivity to paracetamol or codeine which is rare.

Hypersensitivity to any of the other constituents.

Conditions where morphine and opioids are contraindicated e.g:

• Acute asthma

• Respiratory depression

• Acute alcoholism

• Head injuries

• Raised intra-cranial pressure

• Following biliary tract surgery

Monoamine oxidase inhibitor therapy, concurrent or within 14 days.

4.4 Special Warnings And Precautions For Use

Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects. Estimates indicate that up to 7% of the caucasian population may have this deficiency. However, if the patient is an ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at low doses. General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite and somnolence. In severe cases this may include symptoms of circulatory and respiratory depression. Estimates indicate that up to 1 to 2% of the caucasian population may be ultra-rapid metabolisers.

The leaflet will state in the “pregnancy and breast-feeding” subsection of the section 2 “Before taking your medicine”:

Usually it is safe to take Solpadol while breast feeding as the levels of the active ingredients of this medicine in breast milk are too low to cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels in their breast milk. If any of the following side effects develop in you or your baby, stop taking this medicine and seek immediate medical advice; feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.

Care should be observed in administering the product to any patient whose condition may be exacerbated by opioids, particularly the elderly, who may be sensitive to their central and gastro-intestinal effects, those on concurrent CNS depressant drugs, those with prostatic hypertrophy and those with inflammatory or obstructive bowel disorders. Care should also be observed if prolonged therapy is contemplated.

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with alcoholic liver disease.

Patients should be advised not to exceed the recommended dose and not take other paracetamol containing products concurrently.

Patients should be advised to consult a doctor should symptoms persist and to keep the product out of the reach and sight of children.

The risk-benefit of continued use should be assessed regularly by the prescriber.

The leaflet will state in a prominent position in the 'before taking' section:

Do not take for longer than directed by your prescriber.

Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.

Taking a pain killer for headaches too often or for too long can make them worse.

The label will state (To be displayed prominently on outer pack (not boxed) :

Do not take for longer than directed by your prescriber as taking codeine regularly for a long time can lead to addiction.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Paracetamol may increase the elimination half-life of chloramphenicol. Oral contraceptives may increase its rate of clearance. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

The effects of CNS depressants (including alcohol) may be potentiated by codeine.

4.6 Pregnancy And Lactation

There is inadequate evidence of the safety of codeine in human pregnancy. Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage. Both substances have been used for many years without apparent ill consequences and animal studies have not shown any hazard. Nonetheless careful consideration should be given before prescribing the products for pregnant patients. Opioid analgesics may depress neonatal respiration and cause withdrawal effects in neonates of dependent mothers.

Paracetamol is excreted in breast milk but not in a clinically significant amount.

At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant.

However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolites may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant.

If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.

4.7 Effects On Ability To Drive And Use Machines

Patients should be advised not to drive or operate machinery if affected by dizziness or sedation.

4.8 Undesirable Effects

Codeine can produce typical opioid effects including constipation, nausea, vomiting, dizziness, light-headedness, confusion, drowsiness and urinary retention. The frequency and severity are determined by dosage, duration of treatment and individual sensitivity. Tolerance and dependence can occur, especially with prolonged high dosage of codeine.

• Regular prolonged use of codeine/DHC is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is then stopped.

• Prolonged use of a painkiller for headaches can make them worse.

Adverse effects of paracetamol are rare:

Immune system disorders

- Hypersensitivity including skin rash may occur.

- Not known: Anaphylactic shock, angioedema.

There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Very rare occurrence of pancreatitis.

4.9 Overdose

Codeine

The effects of Codeine overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms

Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.

Management

Management should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg.

Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life so large and repeated doses may be required in a seriously poisoned patient. Observe for at least 4 hours after ingestion, or 8 hours if a sustained release preparation has been taken.

Paracetamol

Patients in whom oxidative liver enzymes have been induced, including alcoholics and those receiving barbiturates and patients who are chronically malnourished, may be particularly sensitive to the toxic effects of paracetamol in overdose.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Liver damage is likely in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Anilides, Paracetamol combinations

ATC Code: NO2B E51

Paracetamol is an analgesic which acts peripherally, probably by blocking impulse generation at the bradykinin sensitive chemo-receptors which evoke pain. Although it is a prostaglandin synthetase inhibitor, the synthetase system in the CNS rather than the periphery appears to be more sensitive to it. This may explain paracetamol's lack of appreciable anti-inflammatory activity. Paracetamol also exhibits antipyretic activity.

Codeine is a centrally acting analgesic which produces its effect by its action at opioid-binding sites (μ-receptors) within the CNS. It is a full agonist.

5.2 Pharmacokinetic Properties

Following oral administration of two capsules (ie, a dose of paracetamol 1000mg and codeine phosphate 60mg) the mean maximum plasma concentrations of paracetamol and codeine phosphate were 17.5 μg/ml and 327ng/ml respectively. The mean times to maximum plasma concentrations were 1.03 hours for paracetamol and 1.10 hours for codeine phosphate.

The mean AUC_(0-10) following administration was 48.0μg/ml per hour for paracetamol and 1301ng/ml per hour for codeine.

The bioavailabilities of paracetamol and codeine when given as the combination are similar to those when they are given separately.

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars

6.1 List Of Excipients

Maize starch

Magnesium stearate

Talc

Indigotine E132

Azorubine E122

Titanium dioxide E171

Gelatin

Black iron oxide E172

Shellac

Propylene glycol

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Store in the original package. Do not store above 25°C.

6.5 Nature And Contents Of Container

White, opaque PVC (250μm)/aluminium foil (20μm)/ PVC (15μm) blister packs or White, opaque PVC (250μm)/ 35gsm Glassine (Pergamin) paper/9µm soft temper Aluminium foil contained in cardboard cartons.

Pack sizes of 100 capsules.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS, UK

8. Marketing Authorisation Number(S)

PL 04425/0635

9. Date Of First Authorisation/Renewal Of The Authorisation

4^th December 2008

10. Date Of Revision Of The Text

2 November 2011

LEGAL STATUS

POM

International Apex Bromhexine HCl

International Apex Bromhexine HCl may be available in the countries listed below.

Ingredient matches for International Apex Bromhexine HCl

Bromhexine

Bromhexine hydrochloride (a derivative of Bromhexine) is reported as an ingredient of International Apex Bromhexine HCl in the following countries:

• Philippines

International Drug Name Search

Canasa Rectal

Generic Name: mesalamine (Rectal route)

me-SAL-a-meen

Commonly used brand name(s)

In the U.S.

• Canasa


• Rowasa


• sfRowasa

In Canada

• Mesasal


• Pentasa


• Salofalk

Available Dosage Forms:

• Suppository


• Enema

Therapeutic Class: Gastrointestinal Agent

Chemical Class: Salicylate, Non-Aspirin

Uses For Canasa

Mesalamine is used to treat inflammatory bowel disease, such as ulcerative colitis. This medicine works inside the bowel by helping to reduce inflammation and other symptoms.

Mesalamine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, mesalamine is used in certain patients with the following medical condition:

• Ulcerative colitis, history of—prevent it from occurring again

Before Using Canasa

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of mesalamine in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of mesalamine in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Varicella Virus Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ardeparin


• Certoparin


• Dalteparin


• Danaparoid


• Enoxaparin


• Nadroparin


• Parnaparin


• Reviparin


• Tamarind


• Tinzaparin


• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—The use of mesalamine may make this condition worse.

Proper Use of mesalamine

This section provides information on the proper use of a number of products that contain mesalamine. It may not be specific to Canasa. Please read with care.

For best results, empty your bowel just before using the rectal enema or suppository.

Keep using this medicine for the full time of treatment even if you begin to feel better after a few days. Do not miss any doses.

For patients using the enema form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• Remove the bottles from the protective foil pouch, being careful not to squeeze or puncture them. The enema is an off-white to tan color. Contents of the enemas removed from the foil pouch may darken with time. Slight darkening will not affect the potency of the contents. However, enemas with dark brown contents should be discarded.


• Shake the bottle well to make sure that the medication is thoroughly mixed. Remove the protective cover from the applicator tip. Hold bottle at the neck so that no medicine spills out.


• Lie on your left side with your left leg straight and your right knee bent in front of you for balance. You can also lie in the knee-chest position, on your knees with your chest touching the bed.


• Gently insert the rectal tip of the enema applicator pointed slightly toward your naval to prevent damage to the rectal wall. Tilt the nozzle slightly toward the back and squeeze slowly to cause the enema to flow into your rectum. Steady pressure will discharge most of the medicine. After administering, withdraw and discard the bottle.


• Remain in position for at least 30 minutes to allow the medicine to distribute thoroughly. Retain the medicine all night if possible.

For patients using the suppository form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• Detach one suppository from strip of suppositories. Hold suppository upright and carefully remove the foil wrapper.


• Avoid excessive handling of the suppository, which is designed to melt at body temperature.


• Insert suppository (pointed end first) completely into rectum with gentle pressure. Retain the suppository for 3 hours or longer, if possible, to achieve the best result.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For inflammatory bowel disease:
  
  • For enema dosage form:
    
    • Adults and teenagers—4 grams (1 unit), used as directed, every night for three to six weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For suppository dosage form:
    
    • Adults and teenagers—500 milligrams (mg), inserted into your rectum, two or three times a day for three to six weeks or 1000 mg, inserted into your rectum, one time a day at bedtime for three to six weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Canasa

It is important that your doctor check your progress at regular visits.

Contact your doctor if you develop cramping, acute abdominal pain, bloody diarrhea, fever, headache or rash. These may be symptoms of a serious condition.

Tell your doctor right away if you experience chest pain or shortness of breath.

Check with your doctor if you notice rectal bleeding, blistering, pain, burning, itching, or other sign of irritation not present before you started using this medicine.

Mesalamine rectal enema may stain clothing, fabrics, painted surfaces, marble, granite, vinyl, or other surfaces it touches.

Canasa Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

• Abdominal or stomach cramps or pain (severe)


• anxiety


• back pain (severe)


• bloody, black, or tarry stools


• blue or pale skin


• bright red blood in the stool


• chest pain, possibly moving to the left arm, neck, or shoulder


• chills


• diarrhea (severe)


• fast heartbeat


• fever


• headache (severe)


• nausea or vomiting


• shortness of breath


• skin rash


• stomach cramps, tenderness, pain


• swelling of the stomach


• unusual tiredness or weakness


• watery or bloody diarrhea


• yellow eyes or skin

Incidence not known

• Blood in urine


• change in frequency of urination or amount of urine


• cough


• difficulty in breathing


• drowsiness


• high fever


• increased thirst


• loss of appetite


• lower back or side pain


• painful or difficult urination


• pale skin


• sore throat


• sores, ulcers, or white spots on lips or in mouth


• swelling of feet or lower legs


• swollen glands


• troubled breathing


• unexplained or unusual bleeding or bruising


• weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach cramps or pain (mild)


• gas or flatulence


• headache (mild)


• nausea

Less common or rare

• Acne


• diarrhea


• dizziness


• leg or joint pain


• loss of hair


• rectal pain or irritation

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Canasa Rectal side effects (in more detail)

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More Canasa Rectal resources

• Canasa Rectal Side Effects (in more detail)
• Canasa Rectal Use in Pregnancy & Breastfeeding
• Canasa Rectal Drug Interactions
• Canasa Rectal Support Group
• 6 Reviews for Canasa Rectal - Add your own review/rating

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