Apra

Uses

Apra IV is used for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, the reduction of fever.

Apra is a non-salicylate antipyretic and non-opioid analgesic agent. Apra IV injection is a sterile, clear, colorless, non pyrogenic, isotonic formulation of Apra intended for intravenous infusion.

Apra is also used to associated treatment for these conditions: Acute Gouty Arthritis, Acute Musculoskeletal Pain, Allergies, Ankylosing Spondylitis (AS), Arthritis, Chills, Cold, Cold Symptoms, Common Cold, Common Cold/Flu, Cough, Cough caused by Common Cold, Coughing caused by Flu caused by Influenza, Dyskinesia of the Biliary Tract, Dyskinesia of the Urinary Tract, Febrile Convulsions, Febrile Illness Acute, Fever, Fibromyalgia Syndrome, Flu caused by Influenza, Headache, Joint dislocations, Menstrual Distress (Dysmenorrhea), Mild pain, Muscle Inflammation, Muscle Injuries, Muscle Spasms, Musculoskeletal Pain, Nasal Congestion, Neuralgia, Osteoarthritis (OA), Pain, Pollen Allergy, Postoperative pain, Premenstrual cramps, Rheumatoid Arthritis, Rhinopharyngitis, Rhinorrhoea, Severe Pain, Sinusitis, Soreness, Muscle, Spasms, Spastic Pain of the Gastrointestinal Tract, Sprains, Tension Headache, Toothache, Upper Respiratory Tract Infection, Whiplash Syndrome, Acute Torticollis, Mild to moderate pain, Minor aches and pains, Minor pain, Moderate Pain, Airway secretion clearance therapy, Antispasmodic, Bronchodilation

Dosage

Apra dosage

Adults and adolescents weighing 50 kg and over: the recommended dosage of Apra IV is 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Apra IV of 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of Apra of 4000 mg per day.

Adults and adolescents weighing under 50 kg: the recommended dosage of Apra IV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Apra IV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Apra of 75 mg/kg per day.

Children >2 to 12 years of age: the recommended dosage of Apra IV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Apra IV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Apra of 75 mg/kg per day.

Side Effects

As all paracetamol products, adverse drug reactions are rare (>1/10000, <1/1000) or very rare (<1/10000). Frequent adverse reactions at injection site have been reported during clinical trials (pain and burning sensation). Very rare cases of hypersensitivity reactions ranging from simple skin rash or urticaria to anaphylactic shock have been reported and require discontinuation of treatment. Cases of erythema, flushing, pruritus and tachycardia have been reported.

Precaution

Administration of Apra in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death. Do not exceed the maximum recommended daily dose of Apra. Use caution when administering Apra in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance < 30 ml/min). There were infrequent reports of life-threatening anaphylaxis requiring emergent medical attention. Discontinue Apra IV immediately if symptoms associated with allergy or hypersensitivity occurs. Do not use Apra IV in patients with Apra allergy.

Food Interaction

• Avoid alcohol. Alcohol may increase the risk of hepatotoxicity.

Volume of Distribution

Volume of distribution is about 0.9L/kg. 10 to 20% of the drug is bound to red blood cells. Acetaminophen appears to be widely distributed throughout most body tissues except in fat.

Half Life

The half-life for adults is 2.5 h after an intravenous dose of 15 mg/kg. After an overdose, the half-life can range from 4 to 8 hours depending on the severity of injury to the liver, as it heavily metabolizes acetaminophen.

Clearance

Adults: 0.27 L/h/kg following a 15 mg/kg intravenous (IV) dose. Children: 0.34 L/h/kg following a 15 mg/kg intravenous (IV dose).

Pregnancy & Breastfeeding use

Pregnancy Category C. There are no studies of intravenous Apra in pregnant women; however, epidemiological data on oral Apra use in pregnant women show no increased risk of major congenital malformations. Animal reproduction studies have not been conducted with IV Apra and it is not known whether Apra IV can cause fetal harm when administered to a pregnant woman. Apra IV should be given to a pregnant woman only if clearly needed. There are no adequate and well-controlled studies with Apra IV during labor and delivery; therefore, it should be used in such settings only after a careful benefit-risk assessment. While studies with Apra IV have not been conducted, Apra is secreted in human milk in small quantities after oral administration.

Contraindication

Apra is contraindicated in patients with known hypersensitivity to its active ingredient or to any of the excipients in the intravenous formulation. Also contraindicated in patients with severe hepatic impairment or severe active liver disease

Special Warning

Pediatric Use: The safety and effectiveness of Apra IV for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Apra IV in adults.

Geriatric use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Patients with Hepatic Impairment: Apra is contraindicated in patients with severe hepatic impairment or severe active liver disease and should be used with caution in patients with hepatic impairment or active liver disease. A reduced total daily dose of Apra may be warranted.

Patients with Renal Impairment: In cases of severe renal impairment (creatinine clearance < 30 ml/min), longer dosing intervals and a reduced total daily dose of Apra may be warranted.

Storage Condition

Store in a cool & dry place & away from children. For single use only. The product should be used within 6 hours after opening. Do not refrigerate or freeze.

Innovators Monograph

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