Sapofen 5% Gel

Ibuprofen

50mg/g

SPIMACO (Al Qassim Pharmaceutical Plant)

Pack size	30g Collapsible Tube
Dispensing mode	P
Source	SAUDI ARABIA
Agent	CITY MEDICAL STORE
Retail Price	5.00 AED

Available as:

400mg - Tablets 400mg - Tablets 50mg/g - Gel 600mg - Tablets 600mg - Tablets 100mg/5ml - Suspension

Indications

Sapofen 5% Gel is used for: Rheumatoid arthritis, Osteoarthritis, Pain, Fever, Pericarditis, Dysmenorrhea, Patent ductus arteriosus, Inflammation, Musculoskeletal and joint disorders

Adult Dose

Pain/Fever/Dysmenorrhea 200-400 mg PO q4-6hr; not to exceed 1.2 g unless directed by physician Inflammatory Disease 400-800 mg PO q6-8hr; not to exceed 3.2 g/day Osteoarthritis, Rheumatoid Arthritis 300 mg, 400 mg, 600 mg, or 800 mg PO q6-8hr; not to exceed 3.2 g/day Severe hepatic impairment: Avoid use

Child Dose

Fever 6 months to 12 years 5-10 mg/kg/dose PO q6-8hr; not to exceed 40 mg/kg/day Pain 4-10 mg/kg/dose PO q6-8hr; not to exceed 40 mg/kg/day Juvenile Idiopathic Arthritis 30-50 mg/kg/24hr PO divided q8hr; not to exceed 2.4 g/day

Renal Dose

Significantly impaired renal function: Monitor closely; consider reduced dosage if warranted

Administration

Should be taken with food.

Contra Indications

Active peptic ulcer; hypersensitivity. Neonates with congenital heart disease, suspected necrotising enterocolitis and active bleeding (parenteral).

Precautions

Asthma; renal or hepatic disorders; bleeding disorders; CV disease. Pregnancy, lactation. Lactation: Drug excreted into breast milk; use not recommended (American Academy of Pediatrics committee states that drug is compatible with nursing)

Pregnancy-Lactation

Pregnancy >30 weeks' gestation: May cause premature closure of ductus arteriosus; avoid during 1st and 3rd trimesters Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks' gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to nonaspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and in approximately 2.6% of controls Lactation Drug excreted into human breast milk in extremely low levels Ibuprofen has a short half-life and is considered safe in infants in doses much higher than those excreted in breast milk Considered the preferred choice for analgesia or inflammation in breastfeeding women (LactMed from NIH)

Interactions

Increased risk of GI bleeding w/ warfarin, corticosteroids, SSRIs and aspirin. May reduce the natriuretic effects of diuretics. Reduced antihypertensive effect of ACE inhibitors and angiotensin II receptor antagonists. May increase toxicity of lithium and methotrexate. Increased nephrotoxicity w/ ciclosporin and tacrolimus.

Adverse Effects

Side effects of Ibuprofen : 1-10% Dizziness (3-9%), Epigastric pain (3-9%), Heartburn (3-9%), Constipation (1-3%), Nausea (3-9%), Rash (3-9%), Tinnitus (3-9%), Edema (1-3%), Fluid retention (1-3%), Headache (1-3%), Vomiting (1-3%) <1% Acute renal failure (sometimes with acute tubular necrosis or hyperkalemia, polyuria, azotemia, cystitis, hematuria, decreased creatinine clearance, elevations in blood urea nitrogen (BUN) or creatinine without other manifestations of renal failure) Agranulocytosis, Aplastic anemia, Erythema multiforme, Erythematous macular rashes, Exfoliative dermatitis, Hemolytic anemia (with or without positive direct antiglobulin test results), Neutropenia, Thrombocytopenia (with or without purpura), Toxic epidermal necrolysis (Lyell syndrome) and photosensitivity reactions Potentially Fatal: Severe CV thrombotic events. Severe GI bleeding, ulceration and perforation.

Mechanism of Action

Ibuprofen inhibits synthesis of prostaglandins in body tissues by inhibiting cyclooxygenase-1 and 2. It has anti-inflammatory, analgesic and antipyretic properties.

Note

Sapofen 5% 50mg/g Gel manufactured by SPIMACO (Al Qassim Pharmaceutical Plant). Its generic name is Ibuprofen. Sapofen 5% is availble in United Arab Emirates. Farmaco UAE drug index information on Sapofen 5% Gel is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

Some other brands of Ibuprofen :

Tablets / Extended Release

Advil 12 Hour Back & Joint ^600mg

PFIZER CONSUMER HEALTHCARE, A DIVISION OF PFIZER CANADA INC.

Capsules (Soft Gelatin)

Advil Liqui-Gels ^200mg

PFIZER CANADA INC.

Capsules (Soft Gelatin)

ADVIL ^400mg

PFIZER CONSUMER HEALTHCARE, A DIVISION OF PFIZER CANADA INC.