Terbicort Total Tube

Uses

Dexpanthenol is used for-

• For prevention and treatment of diaper rash in infants.
• For prevention and treatment of cracked or sore nipples in nursing women.
• For prevention and treatment of chafed, cracked or split skin.
• For treatment of light skin wounds and dry skin

Miconazole Topical Cream has an antibacterial effect on Gram-positive bacteria, it may be used in mycoses secondarily infected with such bacteria. Skin and nail infections due to dermatophytes, yeasts and other fungi such as: Tinea capitis, corporis, manuum, pedis, barbae, cruris, unguium or onychomycosis. Pityriasis versicolor, candidiasis of skin and nails, stomatitis angularis, otitis externa.

Miconazole Oral treatment and prevention of fungal infections of the oropharynx and gastrointestinal tract, and of super infections due to Gram-positive bacteria.

Ofloxacin Eye: It is used for the treatment of external ocular infections such as acute & sub-acute conjunctivitis, keratitis, kerato-conjunctivitis, blepharo-conjunctivitis, blepharitis, corneal ulcer and pre-operative prophylaxis in ocular surgery.

Ofloxacin Ear: It is used for the treatment of external ear infections (otitis externa) and certain middle ear infections (otitis media).

Ofloxacin Oral/Injection are used for the treatment of adults with mild to moderate infections caused by susceptible strains.

• Lower Respiratory Tract: Acute bacterial exacerbation of chronic bronchitis lung abscess, pneumonia.
• Gastrointestinal Tract: Enteric fever, shigellosis.
• Multi-drug-resistant Tuberculosis.
• Skin and skin structures: Uncomplicated skin and skin structure infections.
• Sexually Transmitted Diseases: Acute, Uncomplicated urethral and cervical gonorrhoea. Nongonococcal urethritis and cervicitis. Mixed infections of the urethra and cervix.
• Urinary tract: Uncomplicated Urinary Tract Infections, Complicated urinary tract infections.

Terbinafine cream is used for the treatment of the following dermatological infections: interdigital tinea pedis (Athlete’s foot), tinea cruris (jock itch) or tinea corporis (ring worm) due to susceptible organisms and planter tinea pedis (mocasin type) due to Trichophyton spp.

Terbinafine tablet is used for the treatment of onychomycosis of the toe nail or finger nail due to dermatophytes and also by non-dermatophyte fungi.

Terbicort Total Tube is also used to associated treatment for these conditions: Allergic Rhinitis (AR), Bursitis, Canker Sore, Contusions, Dermabrasion, Diaper Rash, Dry Skin, Edema, Hoarseness, Inflammation, Inflammation of Mouth, Insect Bites, Lateral Epicondylitis, Lesions of the Mucous Membranes, Nasal Congestion, Pharyngeal inflammation, Pruritus, Respiratory Tract Infections (RTI), Seasonal Allergic Rhinitis, Sinusitis, Skin Roughness, Sore Throat, Sunburn, Tendinitis, Tooth Extraction Site Healing, Traumatic Injuries caused by Dental Prosthesis, Urticaria, Vitamin Deficiency, Wounds caused by Surgery, Oral of the Tonsils, Dry, cracked skin, Dryness of the nose, Superficial Conjunctival injuries, Superficial Corneal injuries, Superficial Traumatic Injuries of the Nasal Mucosa, Superficial Wounds, Irrigation therapy, Nutritional supplementation, Oropharyngeal antisepsis, Vitamin supplementationAcne Vulgaris, Dermatophytosis, Dermatophytosis of nail, Diaper Dermatitis, Excessive sweating and body odor, Fungal skin infection, Gastrointestinal candidiasis, Infection Mixed, Infections, Fungal of the Skin Folds, Nail candida, Oropharyngeal Candidiasis, Pityriasis versicolor, Ringworm, Seborrheic Dermatitis, Skin candida, Tinea Capitis, Tinea Corporis, Tinea Cruris, Tinea Pedis, Vaginal Candidiasis, Cutaneous candidiasisAcute Bacterial Exacerbation of Chronic Bronchitis (ABECB), Acute Otitis Media, Bacterial Infections, Cervicitis, Community Acquired Pneumonia (CAP), Complicated Urinary Tract Infection, Conjunctivitis, Epididymitis, Hansen's Disease, Nongonococcal urethritis, Otitis Externa, Prostatitis, Skin and Subcutaneous Tissue Bacterial Infections, Spontaneous Bacterial Peritonitis (SBP), Traveler's Diarrhea, Ulcerative keratitis, Acute Pelvic inflammatory disease, Acute, uncomplicated Gonorrhea, Chronic suppurative Otitis media, Uncomplicated CystitisOnychomycosis, Pityriasis versicolor, Sporotrichosis, Tinea Capitis, Tinea Corporis, Tinea Cruris, Tinea Pedis, Cutaneous candidiasis, Severe Tinea Corporis, Severe Tinea Cruris, Severe Tinea Pedis

How Terbicort Total Tube works

Dexpanthenol is an alcohol derivative of pantothenic acid, a component of the B complex vitamins and an essential component of a normally functioning epithelium. Dexpanthenol is enzymatically cleaved to form pantothenic acid, which is an essential component of Coenzyme A, which acts as a cofactor in many enzymatic reactions that are important for protein metabolism in the epithelium.

Dermatological effects of the topical use of dexpanthenol include increased fibroblast proliferation and accelerated re-epithelialization in wound healing. Furthermore, it acts as a topical protectant, moisturizer, and has demonstrated anti-inflammatory properties .

Miconazole is an azole antifungal used to treat a variety of conditions, including those caused by Candida overgrowth. Unique among the azoles, miconazole is thought to act through three main mechanisms. The primary mechanism of action is through inhibition of the CYP450 14α-lanosterol demethylase enzyme, which results in altered ergosterol production and impaired cell membrane composition and permeability, which in turn leads to cation, phosphate, and low molecular weight protein leakage.

In addition, miconazole inhibits fungal peroxidase and catalase while not affecting NADH oxidase activity, leading to increased production of reactive oxygen species (ROS). Increased intracellular ROS leads to downstream pleiotropic effects and eventual apoptosis.

Lastly, likely as a result of lanosterol demethylation inhibition, miconazole causes a rise in intracellular levels of farnesol. This molecule participates in quorum sensing in Candida, preventing the transition from yeast to mycelial forms and thereby the formation of biofilms, which are more resistant to antibiotics. In addition, farnesol is an inhibitor of drug efflux ABC transporters, namely Candida CaCdr1p and CaCdr2p, which may additionally contribute to increased effectiveness of azole drugs.

Ofloxacin acts on DNA gyrase and toposiomerase IV, enzymes which, like human topoisomerase, prevents the excessive supercoiling of DNA during replication or transcription. By inhibiting their function, the drug thereby inhibits normal cell division.

Terbinafine inhibits the enzyme squalene monooxygenase (also called squalene epoxidase), preventing the conversion of squalene to 2,3-oxydosqualene, a step in the synthesis of ergosterol. This inhibition leads to decreased ergosterol, which would normally be incorporated into the cell wall, and accumulation of squalene.

Generation of a large number of squalene containing vesicles in the cytoplasm may leach other lipids away from, and further weaken, the cell wall.

Dosage

Terbicort Total Tube dosage

Check with the doctor or pharmacist if you are unsure how to use Dexpanthenol.

The usual dosage is generally:

• Diaper rash: Apply a thin layer on the baby’s bottom at every diaper change.
• Nipples: Apply a thin layer on the nipples after each nursing session. Wash the nipples thoroughly before the next nursing session.
• Dry/cracked skin or light wounds and chafed skin: Apply to the dry areas and/or to the wound up to 3 times a day.

For oral administration: Dosage is based on 15 mg/kg/day.

• Adults: 1-2 tea-spoonfuls of gel four times daily
• Children aged 6 years and over: One tea-spoonful of gel four times daily
• Children aged 2-6 years: One tea-spoonful of gel twice daily
• Infants under 2 years: Half tea-spoonful of gel twice daily.

For localised lesions of the mouth:

A small amount of gel may be applied directly to the affected area with a clean finger. For topical treatment of the oropharynx, the gel should be kept in the mouth for as long as possible. Treatment should be continued for up to 2 days after the symptoms have cleared.

For oral candidasis, dental prostheses:

Should be removed at night and brushed with the gel.

The dosage is same for all the ages.

For skin infections: Apply some cream to the lesions twice daily and rub it well with finger until it has fully penetrated the skin. All lesions usually disappear after 2 to 5 weeks. Prolong treatment for some 10 days to prevent relapse.

For nail infections: Clip infected nail as shortly as possible. Apply some cream once daily to the infected nail and rub with your finger, cover nail with a non-perforated occlusive plastic bandage.

Also after loosening of the infected nail (from 2-3 weeks onwards) uniterrupted treatment should be continued until the growth of a new nail has set in and definite cure can be observed (usually after seven months or more).

Ofloxacin Eye: Instill 1 drop in the affected eye(s) every 2 to 4 hours for the first two days and then 4 times daily. The length of treatment should not exceed ten days.

Ofloxacin Ear: Instill 1-2 drops in the affected ear(s) twice daily or as needed.

Ofloxacin Intravenous (Adult):

• Skin and soft tissue infections: 400 mg bid infused over at least 1 hr.
• Complicated urinary tract infections: 200 mg daily by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.
• Lower respiratory tract infections, Septicaemia: 200 mg bid by infusion over at least 30 min. Max: 400 mg bid infused over at least 1 hr.

Ofloxacin Oral (Adult):

General dosage recommendations: The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200 mg to 800 mg daily. Up to 400 mg may be given as a single dose, preferably in the morning, larger doses should be given as two divided doses. Ofloxacin tablets should be swallowed with liquid; they should not be taken within two hours of intake of magnesium/aluminium containing antacids or iron preparations since reduction of absorption of ofloxacin can occur.

• Enteric fever: For adults 200 mg, every 12 hours, for 5 days. For children 15 mg/kg/day in 2 divided doses for 3 days.
• Shigellosis: 400 mg single dose.
• Multi-drug-resistant tuberculosis: 400 mg twice daily along with conventional anti-tuberculosis drugs.
• Lower respiratory tract infection: 400 mg daily, increasing, if necessary, to 400 mg twice daily.
• Uncomplicated Urinary Tract Infections: A single dose of 200/400 mg.
• Uncomplicated urethral and cervical gonorrhoea: A single dose of 400 mg.
• Non-gonococcal urethral and cervicitis: 400 mg daily in single or divided doses.
• Complicated Urinary Tract Infection: 200/400 mg/day for 7 days.

Children: Ofloxacin is usually not indicated for use in children or growing adolescents.

Elderly: No adjustment of dosage is required in the elderly.

Topical application:

Terbinafine cream to affected areas once or twice daily for 1-2 weeks may be adequate for fungal infections of the skin but certain infections may require oral Terbinafine tablet therapy.Usual duration of treatment of Terbinafine cream:

• In Tinea corporis and Tinea cruris: 1-2 weeks.
• In Tinea pedis: 2-4 weeks (One week of treatment will normally suffice if the cream is applied twice daily.).
• In Cutaneous candidiasis: 1-2 weeks
• In Pityriasis (tinea) versicolor: 2 weeks.

To prevent relapses in fungal infection, treatment should be continued for a adequate length of time. To apply Terbinafine cream clean and dry the affected areas thoroughly and apply the cream once or twice a day to the affected skin and surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections the application may be covered with a gauze strip, especially at night.

Oral administration:

Terbinafine tablet is essential for hair or nail infections:

• The usual oral dose: Terbinafine 250 mg daily for 2 to 12 weeks depending upon the infection.
• Finger nail onychomycosis: Terbinafine 250 mg once daily for 6 weeks.
• Toe nail onychomycosis: Terbinafine 250 mg once daily for 12 weeks.

May be taken with or without food. Avoid antacids or supplements containing Fe or Zn within 2 hr before or after ofloxacin. Ensure adequate hydration.

Side Effects

As with any medicine, use of Dexpanthenol may cause side effects in some users. Do not be alarmed by the list of side effects. You may not suffer from any of them. Discontinue use and refer to a doctor immediately in the event of: Allergic reaction and/or allergic skin reaction such as: atopic dermatitis, allergic dermatitis, pruritus, redness, rash, eczema, urticaria, local irritation or blistering. If a side effect occurs, worsens, or if you suffer from a side effect not mentioned in this leaflet, consult with the doctor.

Topical application of Miconazole Nitrate has almost no side effect.

For oral gel: Occasionally, nausea and vomiting have been reported, and with long term treatment, diarrhoea. In rare instances, allergic reactions have been reported. There are isolated reports of hepatitis, for which the causal relationship with Miconazole has not been established.

Ofloxacin Eye: Transient ocular irritation, burning, stinging, redness, itching or photophobia have been reported.

Ofloxacin Ear: Mild irritation or mild discomfort in the ear may occur. Symptoms of an allergic reaction include rash, itching, swelling or trouble breathing.

Ofloxacin tablet or injection is generally well tolerated and clinical side-effects of ofloxacin has been quite low. Among the adverse effects gastrointestinal and central nervous systems' reactions are common. Nausea, rash, vomiting, abdominal pain, diarrhoea and gastrointestinal distress are the gastrointestinal adverse effects. Common central nervous system reactions are headache, dizziness and insomnia.

Terbinafine Tablet: Abdominal discomfort, anorexia, nausea, diarrhoea, headache, rash and urticaria occasionally with arthralgia or myalgia. Less frequently taste disturbance. Rarely liver toxicity, photosensitivity, serious skin reactions etc.

Terbinafine Cream: Redness, itching, or stinging; rarely allergic reactions.

Toxicity

Mouse LD50 : 9gm/kg (Intraperitoneal) Mouse: LD50 7gm/kg (Intravenous) Mouse: LD50 15gm/kg (Oral) Rabbit LD50 4gm/kg (Oral)

Miconazole overdose has not been reported. Patients experiencing an overdose are at an increased risk of severe adverse effects such as headache, skin irritation, diarrhea, nausea, vomiting, abdominal pain, and dysgeusia. Symptomatic and supportive measures are recommended.

Miconazole has an oral LD₅₀ of 500 mg/kg in rats.

LD₅₀=5450 mg/kg (orally in mice)

The subcutaneous LD₅₀ in rats and mice is >2g/kg. The TDLO for women is 210mg/kg/6W.

Overdose data with terbinafine is rare, however symptoms are expected to be nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache. Treat overdose with activated charcoal as well as symptomatic and supportive therapy.

Precaution

If the concomitant use of Miconazole and anticoagulants is envisaged, the anticoagulant effect should be carefully monitored and titrated. It is advisable to monitor Miconazole and phenytoin levels, if they are used concomitantly. Particularly in infants and young children, caution is required to ensure that the gel does not obstruct the throat. Hence, the gel should not be applied to the back of the throat and the full dose should be divided into smaller portions. Observe the patient for possible choking.

Patients being treated with Ofloxacin should not expose themselves unnecessarily to strong sunlight and should avoid UV rays. Caution is recommended if the drug is to be used in psychotic patients or in-patients with a history of psychiatric disease.

Prolonged use of eye drops & ear drops may result in overgrowth of non-susceptible organisms and secondary infection respectively.

Terbifine cream is for external use only. Contact with eyes should be avoided.Good general hygiene is necessary in conjunction with the use of Terbinafine in order to prevent reinfection (eg. from underwear, socks,shoes etc).

Terbinafine tablet is not recommended for patients with chronic or active liver disease. Before prescribing terbinafine, pre-existing liver disease should be assessed. Hepatotoxicity may occur in patients with and without pre-existing liver disease. Pretreatment serum transaminase (ALT and AST) tests are advised for all patients before taking terbinafine tablets.

Interaction

Miconazole can inhibit the metabolism of drugs metabolised by the Cytochrome P450-3A and -2C9 families. This can result in an increase or prolongation of their effects, including side effects. Miconazole Oral Gel should not be used during treatment with the following drugs: terfenadine, astemizole,mizolastine, cisapride, triazolam, oral midazolam, dofetilide, quinidine, pimozide, CYP3A4 metabolised HMG-CoA reductase inhibitors such as simvastatin and lovastatin.

Antacids containing magnesium, aluminium or calcium may decrease absorption of ofloxacin. Iron or Zinc may decrease oral absorption of ofloxacin.

In vivo studies have shown that terbinafine is an inhibitor of the CYP450 2D6 isozyme. Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. Co-administration of terbinafine should be done with careful monitoring and may require a reduction in dose of the 2D6-metabolized drug.

Volume of Distribution

Dexpanthenol is readily converted to pantothenic acid which is widely distributed into body tissues, mainly as coenzyme A. Highest concentrations are found in the liver, adrenal glands, heart, and kidneys.

A 1200 mg miconazole vaginal suppository resulted in a calculated apparent volume of distribution of 95 546 L while a 100 mg vaginal cream yielded an apparent volume of distribution of 10 911L.

A single 250mg oral dose of terbinafine has a volume of distribution at steady state of 947.5L or 16.6L/kg.

Elimination Route

Dexpanthenol is soluble in water and alcohol, although insoluble in fats and oil based substances. With the appropriate vehicle, Dexpanthenol is easily penetrated into the skin. Rate of penetration and absorption is reduced when Dexpanthenol is administered as an oil/water formula.

Miconazole given to healthy volunteers as a single 50 mg oral tablet produced a mean C_max of 15.1 ± 16.2 mcg/mL, a mean AUC_0-24 of 55.2 ± 35.1 mcg*h/mL, and a median T_max of 7 hours (range 2.0-24.1). In these patients measurable plasma concentrations ranged from 0.5 to 0.83 mcg/mL.

Topical miconazole is absorbed poorly into the systemic circulation. In pediatric patients aged 1-21 months given multiple topical applications of miconazole ointment for seven days, the plasma miconazole concentration was less than 0.5 ng/mL in 88% of the patients, with the remaining patients having a concentration of 0.57 and 0.58 ng/mL, respectively. Similarly, patients. administered with a vaginal 1200 mg ovule had a mean C_max of 10.71 ng/mL, mean T_max of 18.4 hours, and mean AUC_0-96 of 477.3 ng*h/mL.

Bioavailability of ofloxacin in the tablet formulation is approximately 98%

Oral terbinafine is >70% absorbed but only 40% bioavailable after first pass metabolism, reaching a C_max of 1µg/mL with a T_max of 2 hours an an AUC of 4.56µg*h/mL. Over the course of a week, 1% topical terbinafine's C_max increases from 949-1049ng/cm²

Half Life

Half life have not been reported

Miconazole has a terminal half-life of 24 hours.

9 hours

Oral terbinafine has an effective half life of approximately 36 hours. However, the terminal half life ranges from 200-400 hours as it distributes into skin and adipose tissue. 1% topical terbinafine's half life increases over the first seven days from approximately 10-40 hours.

Clearance

A single 250mg oral dose of terbinafine has a clearance of 76L/h or 1.11L/h/kg.

Elimination Route

Milk of nursing mothers receiving a normal diet contains about 2 ug of pantothenic acid per mL. About 70% of an oral dose of pantothenic acid is excreted unchanged in urine and about 30% in feces.

Miconazole is excreted through both urine and feces; less than 1% of unchanged miconazole is recovered in urine.

Ofloxacin is mainly eliminated by renal excretion, where between 65% and 80% of an administered oral dose of ofloxacin is excreted unchanged via urine within 48 hours of dosing. About 4-8% of an ofloxacin dose is excreted in the feces and the drug is minimally subject to biliary excretion.

Terbinafine is approximately 80% eliminated in urine, while the remainder is eliminated in feces. The unmetabolized parent drug is not present in urine.

Pregnancy & Breastfeeding use

In animals, Miconazole has shown no teratogenic effects but is foetotoxic at high oral doses. The significance of this to man is unknown. However, as with other imidazoles, Miconazole Oral Gel should be avoided in pregnant women if possible. The potential hazards should be balanced against the possible benefits. It is not known whether Miconazole is excreted in human milk. Caution should be exercised when prescribing Miconazole Oral Gel to nursing mothers.

Only small amounts of Miconazole cream are absorbed following local administration. However as with other imidazoles, Miconazole nitrate should be used with caution during pregnancy.

Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in lactation: It is not known whether Ofloxacin is excreted in human milk. Cautions should be taken when Ofloxacin eye & ear drops is administered during lactation.

Terbinafine tablet: There are no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine not be initiated during pregnancy. After oral administration, terbinafine is present in breast milk of nursing mothers. Treatment with terbinafine in not recommended in nursing mothers.

Terbinafine cream: Foetal toxicity and fertility studies in animals suggest no adverse effects. There is no clinical experience with terbinafine in pregnant women; therefore, unless the potential benefits outweigh any potential risk, terbinafine should not be administered. Terbinafine is excreted in breast milk and therefore mothers should not receive terbinafine treatment whilst breast-feeding.

Contraindication

Miconazole is contraindicated in patients with known hypersensitivity to the active drug.

It is contraindicated in patients who are hypersensitive to Ofloxacin or any other component of Ofloxacin (Eye/Ear Drops).

Ofloxacin tablet injection should not be used in-patients with known hypersensitivity to 4-fluoroquinolone antibacterials. It is contraindicated in-patients with a history of epilepsy or with a lowered seizure threshold. Ofloxacin is usually contraindicated in children or growing adolescents and in pregnant or breast feeding women.

Hypersensitivity to Terbinafine or any of the excipients in thepreparation

Special Warning

Renal Impairment:

• CrCl <20 and patients on haemodialysis or peritoneal dialysis: 100 mg 24 hrly following usual initial dose.
• CrCl 20-50: Reduce dose by half 24 hrly following usual initial dose.

Hepatic Impairment:Severe: Reduce dose. Max: 400 mg daily

Use in Children: Terbinafine cream appears to be an effective and well-tolerated treatmenr of tinea corposis and tinea cruris in children.

Use in Elderly: Terbinafine appears to be safe in the elderly. The dose should be reduced by half if significant hepatic or renal impairment is present.

Acute Overdose

In general, Miconazole is not highly toxic. In the event of accidental overdosage, vomiting and diarrhoea may occur.

Symptoms: Confusion, dizziness, impairment of consciousness, convulsive seizures, GI reactions (e.g. nausea, mucosal erosions).

Management: Symptomatic and supportive treatment. Remove any unabsorbed drug by gastric lavage or admin of adsorbants and Na sulfate. Antacids are recommended for protection of gastric mucosa. Elimination may be increased by forced diuresis.

Clinical experience regarding overdose with terbinafine tablets is limited. Doses up to 5 grams (20 times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.

Storage Condition

Do not store above 30 degree Celsius. Keep away from light and out of the reach of children.

Store away from direct heat. Keep out of reach of children.

Store between 15-30° C. Protect from light.

Store in a cool and dry place, protected from light.

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