Ibanox Dosage & Drug Information

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

Concise Prescribing Info

Contents

Ibandronic acid (as Na monohydrate)

Indications/Uses

Osteoporosis in postmenopausal women at increased risk of fracture.

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Dosage/Direction for Use

1 tab once a mth, preferable taken on the same date each mth.

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Overdosage

View Ibanox overdosage for action to be taken in the event of an overdose.

Administration

Should be taken on an empty stomach: Should be taken after an overnight fast (at least 6 hr) & 1 hr before the 1st food or drink (other than water) of the day or any other oral medicinal products or supplements (including Ca). Swallow whole w/ a glass of water (180-240 mL) while sitting or standing in an upright position. Do not lie down for 1 hr. Do not chew or suck the tab.

Contraindications

Hypersensitivity. Hypocalcaemia; abnormalities of the oesophagus which delay oesophageal emptying eg, stricture or achalasia; inability to stand or sit upright for at least 60 min.

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Special Precautions

Correct existing hypocalcaemia & treat other disturbances of bone & mineral metabolism before starting therapy. Ensure adequate intake of Ca & vit D. Risk of upper GI mucosa irritation. Discontinue use if patient develops dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. Reports of osteonecrosis of the external auditory canal, mainly associated w/ long-term therapy. Very rare post-marketing reports of osteonecrosis of the jaw. Reports of atypical subtrochanteric & diaphyseal femoral fractures, primarily in patients receiving long-term treatment for osteoporosis. Consider discontinuation of therapy in patients suspected to have an atypical femur fracture. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended for patients w/ CrCl <30 mL/min. Not to be used during pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Headache; oesophagitis, gastritis, GERD, dyspepsia, diarrhoea, abdominal pain, nausea; rash; arthralgia, myalgia, musculoskeletal pain, muscle cramp, musculoskeletal stiffness; flu-like illness.

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Drug Interactions

Reduced oral bioavailability in the presence of food. Interference of absorption w/ products containing Ca (eg, milk) & other multivalent cations (eg, Al, Mg, Fe). Risk of GI irritation w/ ASA & NSAIDs.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Ibanox detailed prescribing information

Storage

View Ibanox storage conditions for details to ensure optimal shelf-life.

Description

View Ibanox description for details of the chemical structure and excipients (inactive components).

Action

View Ibanox mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Agents Affecting Bone Metabolism

ATC Classification

M05BA06 - ibandronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.

Regulatory Classification

Presentation/Packing

Form

Ibanox FC tab 150 mg

Packing/Price

1's

Ibanox

ibandronic acid

Manufacturer:

Pharmathen

Distributor:

Sandoz