Pas-Fatol N

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Pas-Fatol N uses


INDICATIONS AND USAGE

Pas-Fatol N is indicated for the treatment of tuberculosis in combination with other active agents. It is most commonly used in patients with Multi-drug Resistant TB (MDR-TB) or in situations when therapy with isoniazid and rifampin is not possible due to a combination of resistance and/or intolerance. When Pas-Fatol N is added to the treatment regimen in patients proven or suspected drug resistance, it should be accompanied by at least one and preferably two other new agents to which the patient's organism is known or expected to be susceptible.

CONTRAINDICATIONS

Hypersensitivity to any component of this medication.

Severe renal disease.

Patients with severe renal disease will accumulate Pas-Fatol N acid and its acetyl metabolite but will continue to acetylate, thus leading exclusively to the inactive acetylated form; deacetylation, if any, is not significant.

The half life of free Pas-Fatol N acid in renal disease is 30.8 minutes in comparison to 26.4 minutes in normal volunteers. but the half life of the inactive metabolite is 309 minutes in uremic patients in comparison to 51 minutes in normal volunteers. Although Pas-Fatol N acid passes dialysis membranes, the frequency of dialysis usually is not comparable to the half-life of 50 minutes for the free acid. Patients with end stage renal disease should not receive Pas-Fatol N acid.

WARNINGS

Liver Function

In one retrospective study of 7492 patients on rapidly absorbed Pas-Fatol N acid preparations, drug-induced hepatitis occurred in 38 patients (0.5%); in these 38 the first symptom usually appeared within three months of the start of therapy with a rash as the most common event followed by fever and much less frequently by GI disturbances of anorexia, nausea or diarrhea. Only one patient was diagnosed on routine biochemistry.

Premonitory symptoms in 90% of these 38 patients preceded jaundice by a few days to several weeks with the mean time of onset 33 days with a range of 7-90 days. Half of the adverse reactions occurred during the third, fourth or fifth weeks. When Pas-Fatol N acid-induced hepatitis was diagnosed, hepatomegaly was invariably present with lymphadenopathy in 46%, leucocytosis in 79%, and eosinophilia in 55%. Prompt recognition with discontinuation led to the recovery of all 38 patients. If recognized in the premonitory stage, the reaction is reported to “settle” in 24 hours and no jaundice ensues. From other reported studies failure to recognize the reaction can result in a mortality of up to 21%. The patient must be monitored carefully during the first three months of therapy and treatment must be discontinued immediately at the first sign of a rash, fever or other premonitory signs of intolerance.

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PRECAUTIONS

General:

All drugs should be stopped at the first sign suggesting a hypersensitivity reaction. They may be restarted one at a time in very small but gradually increasing doses to determine whether the manifestations are drug-induced and, if so, which drug is responsible.

Desensitization has been accomplished successfully in 15 of 17 patients starting with 10 mg Pas-Fatol N acid given as a single dose. The dosage is doubled every 2 days until reaching a total of 1 gram after which the dosage is divided to follow the regular schedule of administration. If a mild temperature rise or skin reaction develops, the increment is to be dropped back one level or the progression held for one cycle. Reactions are rare after a total dosage of 1.5 grams.

Patients with hepatic disease may not tolerate Pas-Fatol N acid as well as normal patients, even though the metabolism in patients with hepatic disease has been reported to be comparable to that in normal volunteers.

Information for Patients:

The patient should be advised that the first signs of hypersensitivity include a rash, often followed by fever, and much less frequently, GI disturbances of anorexia, nausea or diarrhea. If such symptoms develop, the patient should immediately cease taking the medication and arrange for a prompt clinical visit.

Patients should be advised that poor compliance in taking anti-TB medication often leads to treatment failure, and, not infrequently, to the development of resistance of the organisms in the individual patient.

Patients should be advised that the skeleton of the granules may be seen in the stool.

The coating to protect the Pas-Fatol N granules dissolves promptly under neutral conditions; the granules therefore should be administered by sprinkling on acidic foods such as apple sauce or yogurt or by suspension in a fruit drink which will protect the coating, but the granules sink and will have to be swirled. The coating will last at least 2 hours in either system. All juices tested to date have been satisfactory; tested are: tomato, orange, grapefruit, grape, cranberry, apple, “fruit punch”.

Patients should be advised to store Pas-Fatol N in a refrigerator or freezer. Pas-Fatol N packets may be stored at room temperature for short periods of time.

Patients should be advised NOT to use if the packets are swollen or the granules have lost their tan color and are dark brown or purple. The patient should inform the pharmacist or physician immediately and return the medication.

Laboratory Tests:

Pas-Fatol N acid has been reported to interfere technically with the serum determinations of albumin by dye-binding, SGOT by the azoene dye method and with qualitative urine tests for ketones, bilirubin, urobilinogen or porphobilinogen.

Drug Interactions:

Pas-Fatol N acid at a dosage of 12 grams in a rapidly available form has been reported to produce a 20 percent reduction in the acetylation of isoniazid, especially in patients who are rapid acetylators; INH serum levels, half lives and excretions in fast acetylators still remain half of the levels seen in slow acetylators with or without p-aminosalicylic acid. The effect is dose related and, while it has not been studied with the current delayed release preparation, the lower serum levels with this preparation will result in a reduced effect on the acetylation of INH.

Pas-Fatol N acid has previously been reported to block the absorption of rifampin. A subsequent report has shown that this blockade was due to an excipient not included in Pas-Fatol N granules. Oral administration of a solution containing both Pas-Fatol N acid and rifampin showed full absorption of each product.

As a result of competition, Vitamin B12 absorption has been reduced 55% by 5 grams of Pas-Fatol N acid with clinically significant erythrocyte abnormalities developing after depletion; patients on therapy of more than one month should be considered for maintenance B12.

A malabsorption syndrome can develop in patients on Pas-Fatol N acid but is usually not complete. The complete syndrome includes steatorrhea, an abnormal small bowel pattern on x-ray, villus atrophy, depressed cholesterol, reduced D-xylose and iron absorption. Triglyceride absorption always is normal.

In one literature report 8 hours after the last dosage of Pas-Fatol N acid at 2 gm qid serum digoxin levels were reduced 40% in two of ten patients but not changed in the remaining eight.

Carcinogenesis, mutagenesis, impairment of fertility:

Sodium aminosalicylate produced an occipital bone defect, probably with a dose response, when administered to ten pregnant Wistar rats at five doses from 3.85 to 385 mg/kg from days 6 to 14. There were no significant changes from controls in any group in corpora lutea, early resorptions, total resorptions, fetal death, litter size, or hematomas. For all except the 77 mg/kg group, fetal weights were significantly greater than controls. Chinchilla rabbits on 5 mg/kg from days 7 to 14 did not show any significant differences as compared to controls for the same parameters studied.

Sodium Pas-Fatol N acid was not mutagenic in Ames tester strain TA 100. In human lymphocyte cultures in-vitro clastogenic effects of achromatic, chromatid, isochromatic breaks or chromatid translocations were not seen at 153 or 600 μg/mL. At 1500 and 3000 μg/mL there was a dose related increase in chromatid aberrations.

Patients on isoniazid and Pas-Fatol N acid have been reported to have an increased number of chromosomal aberrations as compared to controls.

Pregnancy: Pregnancy Category C:

Pas-Fatol N acid has been reported to produce occipital malformations in rats when given at doses within the human dose range. Although there probably is a dose response, the frequency of abnormalities was comparable to controls at the highest level tested (two times the human dosage). When administered to rabbits at 5 mg/kg, throughout all three trimesters, no teratologic or embryocidal effects were seen. Literature reports on Pas-Fatol N acid in pregnant women always report coadministration of other medications. Because there are no adequate and well controlled studies of Pas-Fatol N acid in humans, Pas-Fatol N granules should be given to a pregnant woman only if clearly needed.

Nursing mothers:

After administration of a different preparation of Pas-Fatol N acid to one patient, the maximum concentration in the milk was 1 μg/mL at 3 hours with a half-life of 2.5 hours; the maximum maternal plasma concentration was 70 μg/mL at two hours.

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ADVERSE EFFECTS

The most common side effect is gastrointestinal intolerance manifested by nausea, vomiting, diarrhea, and abdominal pain.

Hypersensitivity reactions: Fever, skin eruptions of various types, including exfoliative dermatitis, infectious mononucleosis-like, or lymphoma-like syndrome, leucopenia, agranulocytosis, thrombocytopenia, Coombs' positive hemolytic anemia, jaundice, hepatitis, pericarditis, hypoglycemia, optic neuritis, encephalopathy, Leoffler's syndrome, vasculitis and a reduction in prothrombin.

Crystalluria may be prevented by the maintenance of urine at a neutral or an alkaline pH.

OVERDOSAGE

Overdosage has not been reported.

DOSAGE AND ADMINISTRATION

Pas-Fatol N granules should be administered with other drugs to which the organism is known or expected to be susceptible. It is most commonly administered to patients with Multi-drug Resistant TB (MDR-TB) or in other situations in which therapy with isoniazid or rifampin is not possible due to a combination of resistance and/or intolerance. The adult dosage of four grams (one packet) three times per day or correspondingly smaller doses in children should be given by sprinkling on apple sauce or yogurt or by swirling in the glass to suspend the granules in an acidic drink such as tomato or orange juice.

DO NOT USE if packet is swollen or the granules have lost their tan color, turning dark brown or purple.

HOW SUPPLIED

Carton of 30 Pas-Fatol N packets (NDC 49938-107-04).

Each packet contains four grams Pas-Fatol N acid.

Pas-Fatol N granules are supplied in packets containing 4 grams of Pas-Fatol N acid for administration three times a day by suspension in an acidic drink or food with a pH less than 5. Examples include apple sauce, yogurt, tomato or orange juice.

Distributors and Pharmacists: Store below 59°F (15°C) (in a refrigerator or freezer).

Patients are urged to store Pas-Fatol N in a refrigerator or freezer. Pas-Fatol N packets may be stored at room temperature for short periods of time.

AVOID EXCESSIVE HEAT. DO NOT USE if packet is swollen or the granules have lost their tan color, turning dark brown or purple.

JACOBUS PHARMACEUTICAL CO. INC.

P.O. Box 5290

Princeton, NJ 08540

2A JULY, 1996

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Pas-Fatol N pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Pas-Fatol N available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Pas-Fatol N destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Pas-Fatol N Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Pas-Fatol N pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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Frequently asked Questions

Can i drive or operate heavy machine after consuming Pas-Fatol N?

Depending on the reaction of the Pas-Fatol N after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Pas-Fatol N not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Pas-Fatol N addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Pas-Fatol N, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Pas-Fatol N consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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