PARFLAM- Oral suspension: Each 5 mL contains: Paracetamol 125 mg + Ibuprofen 100 mg.

 

PARFLAM is an antipyretic, analgesic and anti-inflammatory drug.

 

Paracetamol acts on CNS to produce analgesic and anti-pyretic effect. Ibuprofen exerts its action by inhibiting the biosynthesis and release of prostaglandins. It works by blocking an enzyme in the body known as cyclooxygenase (COX). cyclooxygenase is involved in the production of numerous chemicals in the body, including those known as prostaglandins. Prostaglandins are produced by the body response to the presence of injury or disease and they make the nerves more sensitive to pain impulses. They have an important role in the production of pain,  inflammation and fever. By reducing the amount of Prostaglandin produced and inhibiting its biosynthesis by the body, ibuprofen is able to relieve each of these symptoms.

 

Paracetamol: Paracetamol is well absorbed after oral administration (>95%), it is bound to plasma proteins in small amount (<20%), its apparent volume of distribution is 0.9 L/kg. Paracetamol excreted in the urine and the bile and its plasma half-life is about 2.3 hours.

Ibuprofen: Ibuprofen is well absorbed after oral administration (>95%), it is highly bound to plasma proteins (99%), its apparent volume of distribution is 0.1 L/kg. Ibuprofen excreted in the urine and its plasma half-life is about 2 hours.

 

PARFLAM is indicated for:

- Non-articular rheumatic conditions.

- Osteoarthritis.

- Cervical spondylosis.

- Dysmenorrhoea.

- Infective inflammation.

- Dental &traumatic inflammation.

-  pain, fever associated with inflammation.

 

PARFLAM is contraindicated in:

- patients with known hypersensitivity to any of the active ingredients or any of the excipients.

- patients with impaired kidney or liver function, active peptic ulcer and gastrointestinal bleeding.

 

Dosage in excess of those recommended may cause severe liver function damage. Patients suffering from liver or kidney disease should take paracetamol under medical supervision. Consult a doctor if no relief is obtained from the recommended dosage. Do not use continuously for more than 10 days without consulting a doctor.

 

Cross-sensitivity and/or related problems: Patients sensitive to one of the NSAIDs, may be sensitive to any of the other NSAIDs also. NSAIDs may cause bronchoconstriction or anaphylaxis in aspirin sensitive asthmatics, especially those with aspirin induced nasal polyps, asthma and other allergic reaction.

Geriatrics: NSAIDs induced gastrointestinal ulceration and/or bleeding may be more likely to cause serious consequences, including fatalities, in geriatric patients than in younger adults. In addition, elderly patients are more likely to have age-related renal function impairment, which may increase the risk of NSAIDs-induced hepatic and renal toxicity and may also require dosage reduction to prevent accumulation of the medication.

Dental: NSAIDs may cause soreness, irritation, or ulceration of oral mucosa. Ibuprofen may rarely cause leukopenia and/or thrombocytopenia, which may result in an increased incidence of microbial infection, delayed healing and gingival bleeding. If leukopenia or thrombocytopenia occurs, dental work should be deferred until blood counts have returned to normal, and patients should be instructed in proper oral hygiene.

Surgical: Caution is recommended in patients who require surgery. Most NSAIDs inhibit platelet aggregation and may prolong bleeding time, which may increase intra-and postoperative bleeding. Consideration should be given to discontinuing NSAID treatment of an appropriate length of time prior to elective surgery, depending on the potency and duration of effect of the individual agent on platelet aggregability.  

 

- Cholestyramine: Reduces the absorption of PARFLAM.

- Activated charcoal: if administered immediately after administration, reduces the absorption of PARFLAM.

- Domperidone & metoclopramide: Enhance the absorption of PARFLAM.

- Alcohol: Chronic excessive ingestion of alcohol potentiates hepatotoxicity of PARFLAM.

- Zidovudine: Effects of zidovudine may be decreased.

- Lithium: Raised blood lithium levels.

- Aspirin and other NSAlDs: Increased risk of bleeding and peptic ulcers.

- Methotrexate: PARFLAM increases the risk of toxicity.

- Diazepam: PARFLAM induces impairment of cognitive skills & relaxation of extraocular muscles.

- Pentobarbital: PARFLAM activates the hypnotic effects of pentobarbital.

 

PARFLAM is not safe in pregnancy and also for nursing mothers.

 

Long term use of PARFLAM may lead to gastric ulcers, anti-inflammatory drug induced allergy, asthma, hypertension, hepatic and renal dysfunction, insomnia, vertigo, and abdominal pain. Large doses may cause restlessness, excitement, muscle tremor, tachycardia, liver damage & renal failure with acute tubular necrosis.  

Rarely reported side effects of PARFLAM are nausea, vomiting, epigastric discomfort, dizziness, headache, skin rash.

 

Children: Doses to be taken three times a day.

Age 6 months - 1year: 1/2 teaspoonful.

Age 1-6 years: 1 teaspoonful.

Age 7-12 years: 1-2 teaspoonful.

Adults: 4 teaspoonful 3-4 times a day.

 

Ibuprofen: Symptoms include nausea, vomiting, epigastric pain and headache. Gastric lavage or induced emesis may be used for the treatment. Treatment is supportive.

Paracetamol: Symptoms in the first 24 hours are pallor,  nausea, vomiting, diarrhea, anorexia, abdominal pain and increased sweating. Liver damage may become apparent 12 to 48 hours after ingestion.  Gastric lavage or induced emesis may be used for the treatment. Specific therapy with an antidote such as acetylcysteine or methionine may be necessary.

 

PARFLAM- Oral suspension: A carton package of glass bottle of 100 mL.

 

Store PARFLAM- Oral suspension at temperature below 30°C. protect from light.