Annoxen-S: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Naproxen Na

Indications/Uses

Mild to moderate pain. Migraine in adults. Symptomatic management of musculoskeletal & joint disorders eg, bursitis & tendonitis, acute musculoskeletal, post-op, dental surgery, & postpartum pain, RA, OA, ankylosing spondylitis, acute gouty & juvenile arthritis, headache, toothache, dysmenorrhoea. Migraine prophylaxis. Antipyretic.

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Dosage/Direction for Use

Bursitis, tendonitis & acute musculoskeletal pain Initially 2 tab, then 1 tab every 6-8 hr or 2 tab every 12 hr. Max daily dose: 5 tab on 1st day & 4 tab thereafter. RA, OA, ankylosing spondylitis 2-4 tab daily as single dose or in 2 divided doses. May be increased up to 6 tab daily for up to 6 mth. Acute gouty arthritis Initially 3 tab, then 1 tab every 6-8 hr until attack has subsided. Post-op, dental surgery, & postpartum pain Initially 2 tab, then 1 tab every 6-8 hr. Headache, toothache, fever, dysmenorrhoea & acute pain Initially 2 tab, then 1 tab every 6-8 hr, up to max daily dose of 5 tab on 1st day & 4 tab thereafter. Juvenile arthritis 10 mg/kg daily in 2 divided doses, up to 15 mg/kg daily. Max: 1 g daily. Migraine Adult 3 tab at 1st symptom of impending attack w/ additional 1-2 tab throughout the day if necessary ≥30 min after initial dose. Migraine prophylaxis 2 tab bid.

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Overdosage

View Annoxen-S overdosage for action to be taken in the event of an overdose.

Administration

Should be taken with food: Take w/ food, milk or antacid to decrease GI adverse effect.

Contraindications

Hypersensitivity. Patients w/ attacks of asthma, angioedema, urticaria or rhinitis, & acute nasal cavity inflammation w/ aspirin or NSAIDs; active peptic ulceration; severe heart failure; GI haemorrhage or perforation; dengue hemorrhagic fever. Perioperative pain in setting of CABG surgery. Baseline CrCl <30 mL/min. Severe hepatic or renal impairment. Childn <2 yr.

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Warnings

For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Annoxen-S detailed prescribing information

Special Precautions

Avoid use in patients suspected w/ dengue hemorrhagic fever, or platelet disorders from other causes. Increased risk of GI hemorrhage or ulceration, irritation, inflammation, bleeding & perforation; ischemic stroke & heart disease w/ high dose & long term use. Edema. May affect platelet aggregation. Patients w/ heart disease, HTN, dehydration, heart failure; history of GI ulcer or bleeding. Concomitant use w/ diuretics, ACE inhibitors, ARBs. Renal impairment. Liver dysfunction. Not to be used during pregnancy; avoid NSAIDs in last trimester. Not recommended to use in lactation. Elderly (greater risk of renal toxicity & hyperkalemia).

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Use In Pregnancy & Lactation

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Adverse Reactions

Dizziness, drowsiness, headache, lightheadedness, vertigo; dyspnea; visual disturbances; hearing disturbances, tinnitus; palpitations, edema; abdominal pain, diarrhea, nausea, vomiting, constipation, dyspepsia/indigestion, heartburn, stomatitis, flatulence, ulcer; LFT abnormalities/elevations; abnormal renal function; pruritus, increased sweating, skin eruption; fluid retention; anemia, increased bleeding time, ecchymoses, hemolysis; diaphoresis, thirst. Erythema multiforme, SJS, TEN.

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Drug Interactions

Concomitant use w/ anticoagulants, hydantoins, NSAIDs, sulfonamides or sulfonylurea. Increased risk of GI events w/ SSRIs (eg, fluoxetine, paroxetine, sertraline); warfarin or thrombolytic agents eg, alteplase. Increased plasma conc w/ probenecid. Enhanced toxicity w/ MTX. Reduced BP response to antihypertensive drugs w/ ACE inhibitors (eg, captopril, enalapril, lisinopril) & ARBs (eg, losartan, valsartan, candesartan, irbesartan). Interfere w/ antihypertensive effects of β-blockers eg, propranolol, atenolol, metoprolol. Renal failure & altered efficacy w/ diuretics eg, furosemide, hydrochlorothiazide, spironolactone. Delayed absorption w/ sucralfate & cholestyramine.

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Storage

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Description

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Action

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MIMS Class

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

ATC Classification

M01AE02 - naproxen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.

Thai FDA Category

Presentation/Packing

Form

Annoxen-S FC tab 275 mg

Packing/Price

10 × 10's

Annoxen-S

naproxen

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical