| |
|
|
|
| |
|
|
 |
| |
|
|
|
| |
|
|
Composition |
| |
|
|
|
| |
|
|
Each tablet of FEBRINIL contains: Each 1 ml of FEBRINIL Drops contains: |
| |
|
|
Paracetamol … 650 mg Paracetamol … 100 mg |
| |
|
|
|
| |
|
|
Each 5 ml of FEBRINIL Each 1 ml of FEBRINIL Injection |
| |
|
|
Suspension contains: contains: |
| |
|
|
Paracetamol … 250 mg Paracetamol … 0.150 g |
| |
|
|
Benzyl alcohol (as preservative) … 2% v/v |
| |
|
|
|
| |
|
|
|
| |
|
|
Therapeutic Indications & Usage |
| |
|
|
|
| |
|
|
FEBRINIL is indicated for symptomatic relief of fever, temporary reduction of mild to moderate aches and pain associated with cold, flu, headache, muscular aches, sprains, overexertion and osteoarthritis.In children, FEBRINIL can be useful for simple pain and discomfort due to teething, immunizations and Tonsillectomy. |
| |
|
|
|
| |
|
|
|
| |
|
|
Contraindications |
| |
|
|
|
| |
|
|
FEBRINIL is not advocated for those allergic to its ingredients and in acute severe liver dysfunction.Intravenous (IV) paracetamol (FEBRINIL Injection) is contraindicated in severe hepatocellular insuffi-ciency and hepatic failure. |
| |
|
|
|
| |
|
|
|
| |
|
|
Precautions & Warnings |
| |
|
|
|
| |
|
|
FEBRINIL is to be advocated with caution in liver & kidney damage; it should also be given with caution in those with alcohol dependence. FEBRINIL Injection especially must be advocated with caution in those with a creatinine clearance <30 ml/minute, chronic alcoholism, chronic malnutrition (low reserves of glutathione stores) and dehydration.
|
| |
|
|
|
| |
|
|
In pregnancy and lactation FEBRINIL should be given only if strictly required. There is inadequate safety data for intramuscular (IM) / IV paracetamol (FEBRINIL Injection) use in neonates, infants and
children <6 months of age.
|
| |
|
|
|
| |
|
|
FEBRINIL should be coadministered with due precaution along with prokinetics such as metoclopramide, probenecid and cholestyramine. |
| |
|
|
|
| |
|
|
|
| |
|
|
Adverse Reactions |
| |
|
|
|
| |
|
|
Side effects of paracetamol (FEBRINIL) are rare, and usually mild. Skin rashes and other hypersensitivity reactions could occur, and, on rare occasions, paracetamol could cause hematological changes. Pain at injection site can occur with FEBRINIL IM / IV.
|
| |
|
|
|
| |
|
|
|
| |
|
|
Drug interactions |
| |
|
|
|
| |
|
|
Absorption of paracetamol from FEBRINIL is increased by concomitant metoclopramide, and such other agents. Probenecid can decrease it's clearance whilst cholestyramine diminishes absorption of paracetamol (FEBRINIL) when coadministered. |
| |
|
|
|
| |
|
|
|
| |
|
|
Recommended Dosage & Administration |
| |
|
|
|
| |
|
|
Adults: 1 FEBRINIL Tab / 1-2 tsf FEBRINIL Susp 4-6 hourly, or as prescribed.
Maximum up to 4 gm daily.
|
| |
|
|
|
| |
|
|
Children: Maximum of 4 doses per day. |
| |
|
|
6-12 yrs: ½-1 FEBRINIL Tab / 1-2 FEBRINIL Susp 4-6 hourly, or as prescribed.
1-5 yrs: ¼-½ FEBRINIL Tab / ½-1 tsf FEBRINIL Susp 4-6 hourly, or as prescribed.
3 mths-1 yr: ¼-½ tsf FEBRINIL Susp / 10-20 FEBRINIL Drops 4-6 hourly, or as prescribed.
<3 mths: 10-15 mg/kg bodyweight as FEBRINIL Drops 4-6 hourly, or as prescribed.
|
| |
|
|
|
| |
|
|
Parenteral |
| |
|
|
Adults: 2 ml FEBRINIL Injection IM / IV, or as prescribed. Minimum interval of 4 hours recommended inbetween doses, and 6 hours in those with hepatic and / or renal impairment. Maximum of 1 gm up to 4 times daily. |
| |
|
|
|
| |
|
|
Children (<33 kg): 15 mg/kg FEBRINIL Injection IM / IV up to 4 times daily as required, or as prescribed. Minimum interval of 6 hours recommended in-between doses. Maximum dose is 60 mg/kg per day. |
| |
|
|
|
| |
|
|
Neonates: 7.5 mg/kg FEBRINIL Injection IM / IV up to 4 times daily as required, or as prescribed. Minimum interval of 6 hours recommended in-between doses.
|
| |
|
|
|
| |
|
|
|
| |
|
|
Presentation |
| |
|
|
|
| |
|
|
FEBRINIL Tablets: Blisters of 10s |
| |
|
|
FEBRINIL Drops: Vials of 15 ml. |
| |
|
|
FEBRINIL Suspension: Bottles of 60 ml. |
| |
|
|
FEBRINIL Injection: Ampoules of 2 ml; vials of 15 ml.
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
|
| |
|
|
|
