DRUGS & SUPPLEMENTS

Parasalicil

Name: Parasalicil drug & pharmaceuticals. Available Forms, Doses, Prices
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Published: 2021-11-11T10:10:10+00:00

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Parasalicil uses

Indications and usage
Contraindications
Warnings
Precautions
Adverse effects
Overdosage
Dosage and administration
How supplied
Parasalicil reviews

INDICATIONS AND USAGE

Parasalicil 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 Parasalicil 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 Parasalicil 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 Parasalicil 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 Parasalicil 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 Parasalicil acid.

WARNINGS

Liver Function

In one retrospective study of 7492 patients on rapidly absorbed Parasalicil 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 Parasalicil 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.

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 Parasalicil 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 Parasalicil 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 Parasalicil 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 Parasalicil in a refrigerator or freezer. Parasalicil 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:

Parasalicil 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:

Parasalicil 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.

Parasalicil 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 Parasalicil granules. Oral administration of a solution containing both Parasalicil 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 Parasalicil 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 Parasalicil 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 Parasalicil 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 Parasalicil 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 Parasalicil acid have been reported to have an increased number of chromosomal aberrations as compared to controls.

Pregnancy: Pregnancy Category C:

Parasalicil 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 Parasalicil acid in pregnant women always report coadministration of other medications. Because there are no adequate and well controlled studies of Parasalicil acid in humans, Parasalicil granules should be given to a pregnant woman only if clearly needed.

Nursing mothers:

After administration of a different preparation of Parasalicil 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.

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

Parasalicil 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 Parasalicil packets (NDC 49938-107-04).

Each packet contains four grams Parasalicil acid.

Parasalicil granules are supplied in packets containing 4 grams of Parasalicil 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 Parasalicil in a refrigerator or freezer. Parasalicil 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

Parasalicil pharmaceutical active ingredients containing related brand and generic drugs:

Aminosalicylic Acid (Aminosalicylate)

Parasalicil available forms, composition, doses:

Parasalicil destination | category:

Human:
Anti-TB agents

Parasalicil Anatomical Therapeutic Chemical codes:

J04AA01 - Aminosalicylic Acid

Parasalicil pharmaceutical companies:

Frequently asked Questions

Can i drive or operate heavy machine after consuming Parasalicil?

Depending on the reaction of the Parasalicil after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Parasalicil 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 Parasalicil 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.

Review

sdrugs.com conducted a study on Parasalicil, 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 Parasalicil 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.