Pedityle 

Acetaminophen oral Suspension with flavor of banana twist

Each 5 mL contains acetaminophen 160 mg

Route of administration : Oral

This medication is prescribed for your current condition, please do not use in similar cases and recommend that to others.

Category: Analgesic, antipyretic

Indication: Pain, fever, weak inflammation, vaccination fever

Pharmacokinetics: Acetaminophen has rapid & almost complete absorption, absorption may decrease if acetaminophen is taken following a high carbohydrate meal. Acetaminophen half-life is 1 to 4 hours and it reaches to peak concentration in 0.5 to 2 hours. Acetaminophen is metabolized in liver.

Contraindications: Hypersensitivity to acetaminophen, severe hepatic impairment, sever active renal disease. (martindale 2017)

Pregnancy & breast feeding category: C (martindale 2017)

Pregnancy: Problems in humans have not been documented . Although control study have not been done, it has been shown that acetaminophen crosses the placenta.

Breast feeding: Although acetaminophen is distributed into breast milk, problems in humans have not been documented. 

Adverse reactions:

 Any medication, along with the desired effects, may cause side effects. However, not all of these side effects are seen in one person. Consult your doctor or pharmacist immediately if any of these side effects occur.

Fever with or without chills, ulcers or white spots on lips or mouth, sore throat, anemia ( unusual tiredness or weakness), dermatitis, allergic ( skin rash, hives, itching), hepatitis ( yellow eye or skin), pain, sever &/or sharp in lower back &/or side

Drug interactions: Tell your doctor if you are taking any of the following medicines before taking this medicine:

Risk of hepatotoxicity with single toxic doses or prolonged use of high doses of acetaminophen may be increased in chronic alcoholics or in patientsregularly taking other hepatotoxic or hepatic enzyme inducers medications

Barbiturate : Chronic use of barbiturates (except butalbital) or primidone has been reported to decrease therapeutics effect of acetaminophen.

Anticoagulants: Concurrent chronic high dose administration of acetaminophen may increase the anticoagulant effect.

Anti-inflammatory drugs, aspirin or salicylates: Prolonged concurrent use of acetaminophen & NSAID may increase renal adverse effects.

Dosage & administration: The dosage of each drug is determined by the doctor, but general dosage of this drug is generally as follows:

Note: It is recommended that children up to 12 years of age receive no more than five doses in each 24 hour period, unless otherwise directed by a physician & that a physician be consulted if pain is not relieved within 5 days, fever within 3 days & sore throat within 2 days.

Overdose: The following effects have been selected on the basis of their potential clinical significance

Acute: Gastrointestinal upset (diarrhea, loss of appetite, nausea or vomiting, stomach cramps pain) increased sweating

Chronic: Hepatotoxicity (pain, tenderness &/or swelling in upper abdominal area) may occur 2 to 4 days after the overdose is ingested.

If you notice any of these  symptoms, thepatients should be taken to a doctor or medical services immediately.

Precautions:

Regular visit to physician to check progress if long term therapy is prescribed or additional treatment is needed.

Avoid using alcohol if taking more than an occasional 1 or 2 doses of this medication; increased risk of liver toxicity.

Risk of overdose if other medicines containing acetaminophen are used.

Not using a salicylate or a nonsteroidal anti inflammatory drug together with acetaminophen for more than a few days, unless directed by physician

Possible interference with some laboratory tests; preferably discussing use of the medication with doctor in charge 3 to 4 days ahead of time.

Possible false results with blood glucose tests in diabetic patients.

Getting emergency help at once of overdose suspicious cases because of severe delayed symptoms.

Shake the bottle well before use. 

Wash the scaled measure before & after use. 

Keep the bottle tightly closed.

Storage condition: Store in original package below 30 °C in tight container. Protect from freezing. Keep out of reach of children.

Package: Each box contains 1 polyethylene bottle (60 mL) with scaled measure 15 mL ( divided in 2.5mL ) and leaflet.

MAH: Oxin Darou Vesht Company

Tehran-Iran