H-Paxin

Uses

Short-term treatment of steroid responsive in inflammatory conditions of the eye after clinical exclusion of bacterial, viral or fungal infections. Non-infected inflammatory conditions of the ear or nose.Bupivacaine is indicated for the production of local or regional anaesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures. The routes of administration and indicated Bupivacaine concentrations are: Local infiltration: 0.25% Peripheral nerve block: 0.25%, 0.5% Sympathetic block: 0.25% Lumbar epidural: 0.25%, 0.5% and 0.75% (non-obstetrical) Caudal: 0.25%, 0.5%

Dosage

H-Paxin dosage

Eye: 1 or 2 drops to each affected eye every 1 or 2 hours until control is achieved, then the frequency may be reduced.Ear: 2 or 3 drops to each affected ear every 2 or 3 hours until control is achieved, then the frequency may be reduced.Nose: 2 or 3 drops instilled into each nostril 2 or 3 times daily.Each 30 ml contains 150 mg Bupivacaine Hydrochloride (anhydrous) USP.The dose of any local anaesthetic administered varies with the anaesthetic procedure, the area to be anaesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked. In recommended doses, Bupivacaine produces complete sensory block, but the effect on motor function differs among the three concentrations.0.25% when used for caudal, epidural, or peripheral nerve block, produces incomplete motor block. Should be used for operations in which muscle relaxation is not important, or when another means of providing muscle relaxation is used concurrently. Onset of action may be slower than with the 0.5% or 0.75% solutions.0.5% provides motor blockade for caudal, epidural, or nerve block, but muscle relaxation may be inadequate for operations in which complete muscle relaxation is essential.Maximum dosage limit must be individualized in each case after evaluating the size and physical status of the patient, as well as the usual rate of systemic absorption from a particular injection site. Most experience to date is with single doses of Bupivacaine up to 175 mg. These doses may be repeated up to once every three hours. In clinical studies to date, total daily doses up to 400 mg have been reported. Until further experience is gained, this dose should not be exceeded in 24 hours.The following dosages have generally proved satisfactory and are recommended as a guide for use in the average adult. These dosages should be reduced for young, elderly or debilitated patients. Local Infiltration: 0.25%: up to max (mg) Epidural: 0.5%: 50-100 mg Epidural: 0.25%: 25-50 mg Caudal: 0.5%: 75-150 mg Caudal: 0.25%: 37.5-75 mg Peripheral Nerves: 0.5%: 25 mg to max. Peripheral Nerves: 0.25%: 12.5 mg to max. Sympathetic 0.25%: 50-125 mg

Side Effects

Hypersensitivity reactions may occur leading to irritation, burning, stinging, itching and dermatitis. Topical corticosteroid use may result in corneal ulceration, increased intraocular pressure leading to optic nerve damage, reduced visual acuity. Intensive or prolonged use of topical corticosteroids may lead to formation of posterior subcapsular cataracts. In those diseases causing thinning of the cornea or sclera, corticosteroid therapy may result in thinning of the globe leading to perforation. Mydriasis, ptosis and epithelial punctate keratitis have also been reported following ophthalmic use of corticosteroids.Central Nervous System and Neurological: Restlessness, excitement, nervousness, dizziness, tinnitus, blurred vision, miosis, nausea, vomiting, numbness of the tongue and perioral region, chills, tremors, muscle twitching, convulsions. Cardiovascular System Reactions: Myocardial depression and peripheral vasodilatation resulting hypotension and bradycardia, ventricular arrhythmia, cardiac arrest. Hypersensitivity: urticaria, pruritus, erythema, angioneurotic edema ,tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly, anaphylactoid reactions.

Precaution

Topical corticosteroids should never be given for an undiagnosed red eye. Ophthalmic treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular pressure, cataract formation or unsuspected infections.Local anaesthetics should only be employed by clinicians who are well versed in diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed, and then only after ensuring the immediate availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personal resources needed for proper management of toxic reactions and related emergencies.Should be given cautiously to the elderly, the debilitated and to children, to patients with epilepsy, impaired cardiac conductions, shock, liver damage and myasthenia gravis.The lowest dosage of local anaesthetic that results in effective anaesthesia should be used to avoid high plasma levels and serious adverse effects. The rapid injection of a large volume of local anaesthetic solution should be avoided and fractional (incremental) doses should be used when feasible. Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient's state of consciousness should be performed after each local anaesthetic injection. Because of the risk of systemic adverse effects when local anaesthetics are absorbed too rapidly, they should not be injected into inflamed or infected tissues and should not be applied to damaged mucosa.

Interaction

Specific drug interaction studies have not been conducted.Bupivacaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide‐type local anaesthetics, e.g. certain anti‐arrhythmics, such as lidocaine and mexiletine, since the systemic toxic effects are additive.Specific interaction studies with Bupivacaine and anti arrhythmic drugs class III (e.g. amiodarone) have not been performed, but caution should be advised.

Pregnancy & Breastfeeding use

There are no adequate and well controlled studies for pregnant woman. It should not be used extensively in pregnant woman. There is no information available whether it is secreted in the milk or not.Bupivacaine injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when administered during lactation.

Contraindication

Hypersensitivity to Bupivacaine, other amide type local anaesthetics or other components of these preparations; Intravenous regional anaesthesia; obstetrical paracervical block anaesthesia.

Special Warning

Use in Children: Administration to children under 12 years of age is not recommended until further experience is gained in this group.

Acute Overdose

Long-term intensive topical use may lead to systemic effects.

Storage Condition

This should be protected from light, store below 25°C. Keep out of reach of children. Do not use more than 4 weeks after opening.Keep in a cool & dry place, protected from light. Keep out of the reach of children.

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