ADOLIN 0.1% CREAM AND GEL ®

Composition

Active ingredients: adapalene 0.1%

Indications

ADOLIN is indicated for the topical treatment of acne VULGARIS.

Dosage Administration

ADOLIN should be applied once a day to affected areas after washing in the evening before retiring. A thin film of the gel should be applied, avoiding eyes, lips, and mucous membranes. During the early weeks of therapy, an apparent exacerbation of acne may occur. This is due to the action of the medication on previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after eight to twelve weeks of treatment.

Storage

Store at controlled room temperature 20° - 25º C (68º - 77º F).

Packaging

ADOLIN 0.1% is supplied in 30 gm.:

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AVALON DIAPER RASH CREAM ®

Composition

zinc oxide 8% w/w , dexapanthenol 2% w/w, cetrimide 0.5% w/w, emulgin B2, castor oil, olive oil, cetostearyl alcohol, paraffin oil ,magnesium sulphate, perfume and water

Indications

Soothe and remove diaper rash quickly, also it has an antibacterial effect.

Packaging

Available in 50 ml and 100 ml aluminum tubes

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AVALON POVIDONE-IODINE SHAMPOO ®

Composition

Povidone-Iodine U.S.P. 7.5% w/v

Mechanism of Action

Povidone Iodine is an Iodine complex with Povidone (polyvinyl-pyrrolidone). Like Iodine the solution of the Iodine complex is bactericidal, fungicidal, virucidal, and trichomonacidal without the staining and irritating effect of the Iodine solution. Also the complex has long duration of action due to the continuous release of the free elemental Iodine from the complex.

Indications

AVALON Povidone Iodine shampoo is used for:

- Damaged or chemically treated hair.

- Controls dandruff and remove itching.

- Seborrheic conditions of the scalp associated with erythema, scaling, exfoliation, pityriasis and pruritus, and cases of severe dandruff.

- As a germicidal skin cleanser for prophylaxis of recurrent furunculosis and acute inflammatory skin lesions.

Contraindications

Contraindicated for patients with thyroid disorders.

Contraindicated for patients with known hypersensitivity to Iodine.

Side Effects

It is rare, may include local hypersensitivity.

Precautions

If irritation, redness or swelling develops, stop the medication. Regular use should be avoided in patients on concurrent lithium therapy

Pregnancy and Lactation

Consult your physician before use in case of pregnancy and lactating mothers.

Direction of Use

Remove jewelry, wet the hair with water, and apply a sufficient amount (10-15ml) on the scalp and hair, using a warm water to lather. Rinse and repeat, massaging the scalp gently. Allow lather to remain for at least 5 minutes on the scalp. Work up lather then rinse thoroughly.

Dosage Administration

Twice weekly for 6 to 8 weeks, then once weekly or as directed by the physician.

Storage

Store below 30ºc. Protect from light.

Packaging

Plastic bottle of 125 ml.

For external use only

Avoid contact with the eyes

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AVALON WHITENING CREAM ®

General

Hydroquinone 1.9%

Composition

Each gram contains 19 mg of Hydroquinone USP, Vitamine C, vitamine E, Emulgin B2, Cetostearyl Alcohol, Paraffin Oil, Benzoic Acid, Glycerine Propylene Glycol, Sodium Lauryl Sulfate, Citric Acid, Sodium Metabisulfite, OctylMethoxyCinnamate and Purified Water.

Pharmacology

Hydroquinone application to skin provides depigmentation by inhibition of enzymatic oxidation of tyrosinase to 3,4dihydroxyphylalanine.

Indications

Whitening cream is indicated for the bleaching of melanin hyperpigmentation. Its formula provides gentle and safe way to lighten the skin.

Contraindications

Whitening cream should not be used for patients who are sensitive to any of its components.

Side Effects

No systemic adverse reactions have been reported.

If patient feels any hypersensitivity, discontinue medication and consult your physician

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AVOBAN 2% OINTMENT ®

Composition

Each gram of AVOBAN ointment contains 20 mg of mupirocin in white translucent, water soluble polyethylene glycol base.

Properties

Pharmacodynamics

AVOBAN ointment is topical antibacterial agent active against those organisms responsible for the majority of skin infections, eg. Staphylococcus aureus including methicillin –resistant strains, other staphylococci and streptococci,

It is also active against some gram –ve pathogens such as haemophilus influenza.

Pharmacokinetics

Absorption

AVOBAN penetrates the intact skin but absorption is low.

Execration

Systemically absorbed AVOBAN ointment is rapidly metabolised to inactive metabolite form which is monic acid and quickly execrated by the kidneys.

Indications

Bacterial skin infections e.g impetigo, folliculitis and furunculosis.

Contraindications

Hyper sensitivity to AVOBAN ointment or other ingredients of the base.

Side Effects

Burning localised to the area of application, itching erythema, stinging and dryness.

Same like other antibiotic the prolonged use of AVOBAN can lead to overgrowth of non susceptible organisms including fungi.

Precautions

AVOBAN is not suitable for the ophthalmic or intra-nasal use, avoid use to the eye.

In common with other polyethylene glycol-based ointments , AVOBAN should be used with caution if there is evidence of moderate or severe renal impairment.

Pediatric use

Safety and efficacy of Mupirocin 2% have been established in the range of 2month to 16 years.

Pregnancy and Lactation

Category B.

No data is available if Mupirocin is secreted in human milk.

Dosage Administration

AVOBAN is applied 3 times daily for 10 days , the area can be covered by dressing , patients not showing response within 3-5 days should be re- evaluated

Storage

Store below 30°C

Packaging

AVOBAN ointment is available in 15 & 30 gmaluminium tubes.

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AVOCAINE SPRAY ®

General

Lidocaine 10% w/w

Description

Each gram of Avocaine 10% spray contains 100mg of Lidocaine base (10mg/dose)

Properties

Pharmacodynamic

Avocaine 10% Spray, like other local anesthetics, causes a reversible blockade of impulse propagation along nerve fibers by preventing the inward movement of sodium ions through the nerve membrane. Local anesthetics of the amide-type are thought to act within the sodium channels of the nerve membrane. Local anesthetics drugs may also have similar effects on excitable membranes in the brain and myocardium. If excessive amounts of the drug reach the systemic circulation rapidly, symptoms and signs of toxicity appear, emanating from the central nervous and cardiovascular system. Central nervous system toxicity usually precedes the cardiovascular effects since it occurs at lower plasma concentrations. Direct effects of local anesthetics on the heart include slow conduction, negative inotropism and eventually cardiac arrest.

Pharmacokinetic

Lidocaine is absorbed following topical administration to mucous membranes; its rate and extent of absorption being dependent upon the concentration and total dose administered, the specific site of application, and duration of exposure. In general, the rate of absorption of local anesthetic agents following topical application is most rapid after intratracheal and bronchial administration. Lidocaine is also well absorbed from the gastrointestinal tract, although little of the intact drug appears in the circulation because of biotransformation in the liver. The plasma protein binding of lidocaine is dependent on the drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 microgram of free base per ml, 60 to 80 percent of lidocaine is protein-bound. Binding is also dependent on the plasma concentration of the alpha-1-acid glycoprotein. Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion. Lidocaine is metabolised rapidly by the liver, and metabolites and unchanged drug are excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation, cleavage of the amide linkage and conjugation. N-dealkylation, a major pathway of biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide. The pharmacological/toxicological actions of these metabolites are similar to, but less potent than, those of lidocaine. Approximately 90% of lidocaine administered is excreted in the form of various metabolites, and less than 10% is excreted unchanged. The primary metabolite in urine is a conjugate of 4-hydroxy-2, 6-dimethylaniline. The elimination half-life of lidocaine following an intravenous bolus injection is typically 1.5 to 2.0 hours. Because of the rapid rate at which lidocaine is metabolised, any condition that affects liver function may alter lidocaine kinetics. The half-life may be prolonged two-fold or more in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics but may increase the accumulation of metabolites.

Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels of lidocaine required to produce overt systemic effects. Objective adverse manifestations become increasingly apparent with increasing venous plasma levels above 6.0 microgram free base per ml.

Indications

For the prevention of pain associated with the following procedures:

Dental Practice

Before injections, dental impression, X-ray photography, removal of calculus. Introduction of instruments, tubes and catheters into the respiratory and digestive tract

Provides surface anesthesia for the oropharyngeal and tracheal areas to reduce reflex activity, attenuate hemodynamic response and to facilitate insertion of the tube or the passage of instruments during endotracheal intubation, laryngoscopy, bronchoscopy and oesophagoscopy.

Obstetrics

During the final stages of delivery and before episiotomy and perineal suturing as supplementary pain control.

Otorhinolaryngology

– Puncture of the maxillary sinus and minor surgical procedures in the nasal cavity, pharynx and epipharynx.

- Paracentesis.

Contraindications

Known history of hypersensitivity to local anesthetics of the amide type or to any other components of the spray solution.

Side Effects

In extremely rare cases amide-type local anesthetic preparations have been associated with allergic reactions (in the most severe instances anaphylactic shock). Local irritation at the application site has been described. Following application to laryngeal mucosa before endotracheal intubation, reversible symptoms such as “sore throat”, “hoarseness” and “loss of voice” have been reported. The use of Avocaine 10% Spray provides surface anesthesia during an endotracheal procedure but does not prevent post-intubation soreness. Systemic adverse reactions are rare and may result from high plasma levels due to excessive dosage or rapid absorption (e.g. following application to areas below the vocal chords) or from hypersensitivity, idiosyncrasy or reduced tolerance on the part of the patient. Such reactions involve the central nervous system and/or the cardiovascular system.

CNS reactions are excitatory and/or depressant and may be characterized by nervousness, dizziness, convulsions, unconsciousness and possibly respiratory arrest. The excitatory reactions may be very brief or may not occur at all, in which case the first manifestations of toxicity may be drowsiness, merging into unconsciousness and respiratory arrest.

Cardiovascular reactions are depressant and may be characterized by hypotension, myocardial depression, bradycardia and possibly cardiac arrest.

Precautions

Excessive dosage or short intervals between doses, may result in high plasma levels and serious adverse effects. Absorption from wound surfaces and mucous membranes is relatively high, especially in the bronchial tree. Avocaine 10% Spray should be used with caution in patients with traumatized mucosa and/or sepsis in the region of the proposed application. If the dose or site of administration is likely to result in high blood levels, Avocaine 10% Spray, in common with other local anesthetics, should be used with caution in patients with epilepsy, cardiovascular disease and heart failure, impaired cardiac conduction, bradycardia, severe renal dysfunction, impaired hepatic function and in severe shock. Avocaine 10% Spray should also be used with caution in the elderly and patients in poor general health. In paralyzed patients under general anesthesia, higher blood concentrations may occur than in spontaneously breathing patients. Unanalyzed patients are more likely to swallow a large proportion of the dose, which then undergoes considerable first-pass hepatic metabolism following absorption from the gut. The oropharyngeal use of topical anesthetic agents may interfere with swallowing and thus enhance the danger of aspiration. This is particularly important in children because of their frequency of eating. Numbness of the tongue or buccal mucosa may increase the danger of biting trauma. Avoid contact with the eyes. Patients treated with antiarrhythmic drugs class III (e.g. amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive. Avocaine 10% Spray should not be used on cuffs of endotracheal tubes (ETT) made of plastic. Avocaine 10% Spray base in contact with both PVC and non-PVC cuffs of endotracheal tubes may cause damage of the cuff. This damage is described as pinholes, which may cause leakage that could lead to pressure loss in the cuff.

Pregnancy and Lactation

In considering that a large number of pregnant women and women of child-bearing age have been given lidocaine. No specific disturbances to the reproductive process have so far been reported, e.g. no increased incidence of malformations. Like other local anesthetics lidocaine may enter the mother's milk, but in such small amounts that there is generally no risk of this affecting the neonate.

Effects on ability to drive and use machines

Depending on the dose, local anesthetics may have a very mild effect on mental function and may temporarily impair locomotion and coordination.

Overdosage

Acute systemic toxicity

Toxic reactions originate mainly in the central nervous and the cardiovascular systems.

Central nervous system toxicity is a graded response with symptoms and signs of escalating severity. The first symptoms are circumoralparaesthesia, numbness of the tongue, light-headedness, hyperacusis and tinnitus. Visual disturbance and muscular tremors are more serious and precede the onset of generalized convulsions. Unconsciousness and grand mal convulsions may follow, which may last from a few seconds to several minutes. Hypoxia and hypercarbia occur rapidly following convulsions due to the increased muscular activity, together with the interference with normal respiration. In severe cases, apnea may occur. Acidosis increases the toxic effects of local anesthetics.

Cardiovascular effects are only seen in cases with high systemic concentrations. Severe hypotension, bradycardia, arrhythmia and cardiovascular collapse may be the result in such cases. Cardiovascular toxic effects are generally preceded by signs of toxicity in the central nervous system, unless the patient is receiving a general anesthetic or is heavily sedated with drugs such as a benzodiazepine or barbiturate. Recovery is due to redistribution and metabolism of the local anesthetic drug from the central nervous system. Recovery may be rapid unless large amounts of the drug have been administered.

Treatment of acute toxicity

The objectives of treatment are to maintain oxygenation, stop convulsions and support the circulation. The necessary drugs and equipment should be immediately available. Ventilation should be maintained with oxygen by assisted or controlled respiration as required. An anticonvulsant should be given i.v. if the convulsions do not stop spontaneously in 15–20 sec. Thiopentone 100-150mg i.v. will abort the convulsions rapidly. Alternatively, diazepam 5-10mg i.v. may be used, although its action will be slow. Suxamethonium will stop the muscle convulsions rapidly, but will require tracheal intubation and artificial ventilation, and should only be used by those familiar with these procedures. If cardiovascular depression is evident (hypotension, bradycardia), ephedrine 5–10 mg i.v. should be given and repeated, if necessary, after 2–3 minutes. Should circulatory arrest occur, immediate cardiopulmonary resuscitation should be instituted. Optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis are of vital importance, since hypoxia and acidosis will increase the systemic toxicity of local anesthetics. Adrenaline 0.1-0.2 mg as intravenous or intracardiac injections should be given as soon as possible and repeated if necessary.

Children should be given doses commensurate with their age and weight

Drug Interactions

Avocaine 10% Spray should be used in caution with patients receiving agents structurally related to local anesthetics, e.g. tocainide, since the toxic effects are additive.

Dosage Administration

Avocaine 10% Spray is intended for use on mucous membranes and provides efficient surface anesthesia, which lasts for approximately 10-15 minutes. The anesthesia usually occurs within 1-5minutes, depending on the area of application. The following dosage recommendations should be regarded as a guide; the clinician's experience and knowledge of the patient's physical status are of importance in calculating the proper required dose. As with any local anesthetic, reactions and complications are best averted by employing the minimal effective dosage. Debilitated or elderly patients and children over 12 years should be given doses commensurate with their age and physical condition.

In children less than 12 years of age the dose should not exceed 3mg/Kg. and when used mainly in the larynx and trachea the dose should be reduced to 1.5 mg/Kg.

In children less than 3 years of age less concentrated lidocaine solutions are recommended.

Each activation of the metered dose valve delivers 10 mg lidocaine base. It is unnecessary to dry the site prior to application.

No more than 20 spray applications should be used in any adult to produce the desired anesthetic effect.

The number of sprays depend on the extent of the area to be anaesthetized.

Dental practice

1–5 applications to the mucous membranes.

Otorhinolaryngology

3 applications for puncture of the maxillary sinus.

During delivery

Up to 20 applications (200 mg lidocaine base).

Introduction of instruments and catheters into the respiratory and digestive tract

Up to 20 applications (200 mg lidocaine base) for procedures in pharynx, larynx, and trachea.

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AVOCIN 1% ®

General

(clindamycin phosphate topical solution, concentration equivalent to 10 mg clindamycin per 1 ml alcohol and water solution.

Composition

AVOCIN 1% Topical Solution and AVOCIN 1% Topical solution contain clindamycin phosphate, at a concentration equivalent to 10 mg clindamycin per milliliter.

AVOCIN 1% Topical Solution applicator is designed to provide facility to use the medication.

Clindamycin Phosphate molecule: