Ace Syrup100 ml

Generic

Paracetamol

Indications

Fever, common cold and influenza : Headache, toothache, earache, bodyache, myalgia, dysmenorrhoea, neuralgia and sprains. Pain of colic, back pain, post-operative pain, postpartum pain, chronic pain of cancer, inflammatory pain, and post-vaccination pain and fever of children. Rheumatism and osteoarthritic pain & stiffness of joints in fingers, hips, knees, wrists, elbows, feet, ankles and top & bottom of the spine. 

Pharmacology

Ace® is the formulation of Paracetamol, which is one of the safest and most widely used analgesic and antipyretic. Ace® produces analgesic action by elevation of the pain threshold and antipyresis through action on the hypothalamic heat regulating centre. Ace® exerts significantly milder side effects and most unlikely to produce many of the serious side effects associated with aspirin and other NSAIDs. Ace® is rapidly and completely absorbed from the G.I.T. following oral administration and from rectum after
rectal administration. The mean half-life of absorption from the upper small intestine is only 7 minutes. The drug is extensively metabolized in the liver and it has a plasma half-life of 1.5 to 3.0 hours. Ace® is not bound to plasma proteins to any extent.

Dosage & Administration

Tablet:

• Adult: 1-2 tablets every 4 to 6 hours up to a maximum of 4 gm (8 tablets) daily.
• Children (6-12 years): ½ to 1 tablet 3 to 4 times daily. For long term treatment it is wise not to exceed the dose beyond 2.6 gm/day.

Extended Release Tablet:

• Adults & Children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours).The tablet must not be crushed.

Syrup/Suspension:

• Children under 3 months: 10 mg/kg body weight (reduce to 5 mg/kg if jaundiced) 3 to 4 times daily.
• 3 months to below 1 year: ½ to 1 teaspoonful 3 to 4 times daily.
• 1-5 years: 1 -2 teaspoonful 3 to 4 times daily.
• 6-12 years: 2-A teaspoonful 3 to 4 times daily.
• Adults: 4-8 teaspoonful 3 to 4 times daily.

Suppository:

• Children 3-12 months: 60-120 mg,4 times daily.
• Children 1-5 years: 125-250 mg 4 times daily.
• Children 6-12 years: 250-500 mg 4 times daily.
• Adults & children over 12 years: 0.5-1 gm 4 times daily.

Paediatric Drop:

• Children Upto 3 months: 0.5 ml (40 mg)
• 4 to 11 months: 1.0 ml (80 mg)
• 7 to 2 years: 1.5 ml (120 mg). Do not exceed more than 5 dose daily for a maximum of 5 days.

Paracetamol tablet with actizorb technology: It dissolves up to five times faster than standard Paracetamol tablets. It is a fast acting and safe analgesic with marked antipyretic property. It is specially suitable for patients who, for any reason, can not tolerate aspirin or other analgesics.

• Adults and children (aged 12 years and over): Take 1 to 2 Tablets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.
• Children (7 to 11 years): Take ½-1 Tablet every four to six hours as needed. Do not take more than 4 caplets in 24 hours. Not recommended in children under 7 years.

Interactions

Patients taking barbiturates, tricyclic antidepressants, and alcohol may have a reduced ability to metabolize large doses of paracetamol. Alcohol can increase liver toxicity from acetaminophen overdose. Long-term use of oral contraceptives or steroidal contraceptives may induce liver enzymes and may prevent therapeutic levels of paracetamol from being achieved by increasing metabolism or first-pass clearance.

Contraindications

Known sensitivity to paracetamol. 

Side Effects

Side effects are significantly mild, though haematological reactions have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.

Pregnancy & Lactation

Paracetamol is safe in all stages of pregnancy and lactation.

Precautions & Warnings

Paracetamol should be used with caution in patients with impaired kidney or liver function. Patients taking other medications that affect the liver should use acetaminophen with caution.

Therapeutic Class

Non opioid analgesics

Storage Conditions

Ace® tablet, syrup and suspension: Store at a cool and dry place, protect from light and moisture. Ace® suppository : Store below 30˚ C.

Pharmaceutical Name

Square Pharmaceuticals Ltd.