CUTIS 250MG TAB 10’Suses side-effects dose price in Pakistan
CUTIS 250MG TAB 10’S
Each tablet contains:
Terbinafine (as HCL)……….125
Terbinafine (as HCL)………250
Table of Contents
CUTIS 250MG TAB 10’S Uses/INDICATIONS:
CUTIS 250MG TAB Uses
Onychomycosis (fungal infections of the nail) caused by dermatophyte fungi.
Fungal infections of the skin for the treatment of tinea corporal. Tinea cruris, tinea pedis, and yeast infections of the skin caused by the genus candida (e.g Candida Albicans) where oral therapy is generally considered appropriate owing to the site, severity, or extent of the infection.
NOTE: In contrast to topical cutis, oral cutis is not effective in pityriasis Versicolor.
CUTIS 250MG TAB Dose and ADMINISTRATION:
CUTIS 250MG TAB Dose
The duration of treatment varies according to the indication and the severity of the infection.
Children: No dates are available for children under two years of age (usually <12kg).
Children weighing: <20kg 62.5mg. (Hlaf 125mg tablets)once daily.
Children weighing: 20 to 40kg. 125mg. (One 125mg tablets)once daily.
Children weighing: > 40kg.
250mg. (Two 125mg tablets) once daily.
Adults: 250mg once daily.
Recommended duration of treatment:
Tinea pedis (interdigital, plantar/moccasin type) 2 to 6 weeks.
Tinea corporal, cruris: 2 to 4 weeks
Cutaneous candidiasis: 2 to 4 weeks.
Complete resolution of the signs and symptoms of infection may not occur until several weeks after mycological cure.
HAIR AND SCALP INFECTIONS:
Recommended duration of treatment.
Tinea capitis: 4 weeks.
Tinea capitis occurs primarily in children.
For the patient, the duration of successful treatment is 6 to 12 weeks.
Six weeks of therapy is sufficient for fingernail infection in most cases.
Twelve weeks of therapy is sufficient for toenail infections in most cases.
Some patients with poor nail outgrowth may require longer treatment. The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.
USE OF CUTIS IN THE ELDERLY:
There is no evidence to suggest that elderly patients require different dosages or experience different side effects than younger patients. When prescribing tablets for patients in this age group. The possibly of pre-existing impairment of liver or kidney function should be considered.
USE OF CUTIS IN CHILDREN:
In Children above 2 years of age, oral cutis has to been found well tolerated.
CUTIS 250MG TAB CONTRAINDICATIONS:
Hypersensitivity to Terbinafine and any of the excipients.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE:
Cutis is not recommended for patients with chronic or active liver disease. Before prescribing Cutis tablets, the preexisting liver disease should be assessed. Hepatotoxicity may occur in patients with and without pre-existing liver disease, patients prescribed cutis tablets should be warned to report immediately any symptoms of unexplained persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain, or jaundice, dark urine or pale stools, patients with these symptoms should discontinue taking oral Terbinafine and the patients liver function should be immediately evaluated.
Patients with impaired renal function (creatinine clearance less than 50ml/min or serum creatinine of more than 300micro mol/L) should receive half the normal dose. In vitro and in vivo studies have shown that Terbinafine inhibits the CYP2D6 metabolism, Therefore, patients receiving concomitant treatment (TCAs)- Type B should be followed up if the co-administered drug has a narrow therapeutic window. Cutis tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or galactose malabsorption should not take Cutis tablets.
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION:
According to the results from studies undertaken in vitro and in healthy volunteers, Terbinafine shows negligible potential for inhibiting or enhancing the clearance of most drugs that are metabolized via the cytochrome P450 system (e.g Terbinafine, triazolam, tolbutamide or oral contraceptives).
Terbinafine does not interfere with the clearance of antipyrine or digoxin.
Some cases of menstrual irregularities have been reported in patients taking cutis concomitantly with contraceptives, although the incidence of these disorders remains within the background incidence of patients taking oral contraceptives alone.
USE DURING PREGNANCY AND LACTATION:
Fetal toxicity and fertility studies in animals suggest no adverse effects. Since clinical experience in pregnant women is very limited, cutis should not be used during pregnancy unless the potential benefits outweigh any potential risks. Terbinafine is excreted in breast milk, mother’s receiving oral treatment with cutis should therefore not breast-feed.
CUTIS 250MG TAB Side-EFFECTS:
CUTIS 250MG TAB Side-Effects
In general cutis, tablets are well tolerated. Side effects are usually mild to moderate and transient. The following adverse reactions have been observed in the clinical trial or during post-marketing experience. Adverse reactions are ranked under the heading of frequency using the following convention. Very common >1/10, common >1/100, <1/10, uncommon >1/10>1/100; rare >1/10,100<1/1000 very rare <1/10,1000,including isolated reports.
very rare: Anaphylactoid reactions (including angioedema).
BLOOD AND THE LYMPHATIC SYSTEM DISORDERS:
Very rare: Neutropenia, agranulocytosis, thrombocytopenia.
IMMUNE SYSTEM DISORDERS:
Very rare: Cutaneous and systemic lupus erythematosus.
NERVOUS SYSTEM AND PSYCHIATRIC DISORDERS:
Uncommon: Taste disturbances, including taste loss. Which usually recover within several weeks after discontinuation of the drug. Isolated cases of prolonged taste disturbances have been reported. A decrease in food intake leading to significant weight loss was observed in very few Severe cases.
Rare: Hepatobiliary dysfunction (primarily cholestatic in nature), including very rare cases of serious liver failure (some with a fatal outcome, or requiring liver transplant). In the majority of liver failure cases, the patients had serious underlying systemic conditions and a causal association with the intake of cutis was uncertain.
Very common: Gastrointestinal symptoms (feeling of fullness, loss of appetite, dyspepsia, nausea, mild abdominal pain, and diarrhea).
SKIN AND SUBCUTANEOUS TISSUES DISORDERS:
Very common: Non-serious forms of skin reactions (rash, urticaria).
Very rare: Serious skin reactions (e.g Steven’s Johnson syndrome, toxic epidermal necrolysis).
If progressive skin rash occurs, Cutis treatment should be discontinued.
Hair loss, although a causal relationship has not established.
MUSCULOSKELETAL, CONNECTIVE TISSUE, AND BONE DISORDERS:
Very common: Musculoskeletal reactions (arthralgia, myalgia).
CUTIS 250MG TAB OVERDOSE:
A few cases of overdosage (up to 5 g) have been reported, giving rise to headache, nausea, epigastric pain, and dizziness.
The recommended treatment of overdosage consists of eliminating the drug, primarily by the administration of activated charcoal, and giving symptomatic supportive therapy, if needed.
CUTIS 250MG TAB Price in Pakistan
CUTIS 250MG TAB in Pakistan is 460 rupees 20 tablets Pack.