Dermikem OC Side effects

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Consists of Clobetasol, Ofloxacin, Ornidazole, Terbinafine

What are the possible side effects of Clobetasol (Dermikem OC)?

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dryness; mild burning, itching, or stinging; mild sore throat or runny nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Clobetasol (Dermikem OC); dark red blotches on the skin; excessive hair growth; general feeling of being unwell; inflamed hair follicles; inflammation around the mouth; muscle weakness; numbness of fingers; persistent sore throat, cough, or congestion; severe or persistent headache; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; confusion; drowsiness; flushing; rapid breathing; fruit-like breath odor); thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side effects of Clobetasol (Dermikem OC) in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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In a controlled pharmacokinetic study, 5 of 13 subjects experienced reversible suppression of the adrenals at any time during the 14 days of Clobetasol (Dermikem OC) (clobetasol propionate) Foam therapy to at least 20% of the body surface area. Of the 13 subjects studied, 1 of 9 with psoriasis were suppressed after 14 days and all 4 of the subjects with atopic dermatitis had abnormal cortisol levels indicative of adrenal suppression at some time after starting therapy with Clobetasol (Dermikem OC) (clobetasol propionate) Foam.

Table 3: Subjects with reversible HPA axis suppression at any time during treatment

Dermatosis Clobetasol (Dermikem OC) Foam
Psoriasis 1 of 9
Atopic Dermatitis* 4 of 4
*Clobetasol (Dermikem OC) Foam is not indicated for non-scalp atopic dermatitis, as the safety and efficacy of Clobetasol (Dermikem OC) Foam in non-scalp atopic dermatitis has not been established. Use in children under 12 years of age is not recommended.

Systemic absorption of topical corticosteroids has produced reversible adrenal suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

In a controlled clinical trial (188 subjects) with Clobetasol (Dermikem OC) (clobetasol propionate) Foam in subjects with psoriasis of the scalp, there were no localized scalp adverse reactions reported in the Clobetasol (Dermikem OC) (clobetasol propionate) Foam treated subjects. In two controlled clinical trials (360 subjects) with Clobetasol (Dermikem OC) (clobetasol propionate) Foam in subjects with psoriasis of non-scalp regions, localized adverse events that occurred in the Clobetasol (Dermikem OC) (clobetasol propionate) Foam treated subjects included application site burning (10%), application site dryness ( < 1%), and other application site reactions (4%).

In larger controlled trials with other clobetasol propionate formulations, the most frequently reported local adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, skin atrophy, and telangiectasia (all less than 2%).

The following additional local adverse reactions have been reported with topical corticosteroids, but they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids such as Clobetasol (Dermikem OC) (clobetasol propionate) Foam. These reactions are listed in an approximate decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae, and miliaria.

What is the most important information I should know about Clobetasol (Dermikem OC)?

Clobetasol (Dermikem OC) contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with clobetasol topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Do not use this medication on a child without medical advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

Contact your doctor if your condition does not improve within 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection.

What are the possible side effects of Ofloxacin (Dermikem OC)?

Get emergency medical help if you have signs of an allergic reaction to Ofloxacin (Dermikem OC): hives, or the first sign of a skin rash; fast heartbeat, difficult breathing; swelling of your face, lips, tongue, or throat.

Ofloxacin may cause swelling or tearing of (rupture) a tendon. Ofloxacin can also have serious effects on your nerves, and may cause permanent nerve damage.

Stop using Ofloxacin (Dermikem OC) and call your doctor at once if you have:

Common Ofloxacin (Dermikem OC) side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Ofloxacin (Dermikem OC) in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Ofloxacin (Dermikem OC): The following is a compilation of the data for ofloxacin based on clinical experience with both the oral and IV formulations. The incidence of drug-related adverse reactions in patients during phase 2 and 3 clinical studies (conducted by innovator) was reported to be 11%. Among patients receiving multiple-dose therapy, 4% discontinued ofloxacin due to adverse experiences.

In reported clinical studies, the following events were considered likely to be drug-related in patients receiving multiple doses of ofloxacin: Nausea 3%, insomnia 3%, headache 1%, dizziness 1%, diarrhea 1%, vomiting 1%, rash 1%, pruritus 1%, external genital pruritus in women 1%, vaginitis 1% and dysgeusia 1%.

In reported clinical studies, the most frequently reported adverse events, regardless of relationship to drug, were: Nausea 10%, headache 9%, insomnia 7%, external genital pruritus in women 6%, dizziness 5%, vaginitis 5%, diarrhea 4%, vomiting 4%.

In reported clinical studies, the following events, regardless of relationship to drug, occurred in 1-3% of patients: Abdominal pain and cramps, chest pain, decreased appetite, dry mouth, dysgeusia, fatigue, flatulence, gastrointestinal distress, nervousness, pharyngitis, pruritus, fever, rash, sleep disorders, somnolence, trunk pain, vaginal discharge, visual disturbances and constipation.

Additional events, reported in clinical studies at a rate of <1%, regardless of relationship to drug, were: Body as a Whole: Asthenia, chills, malaise, extremity pain, pain, epistaxis.

Cardiovascular System: Cardiac arrest, edema, hypertension, hypotension, palpitations, vasodilation.

Gastrointestinal System: Dyspepsia.

Genital/Reproductive System: Burning, irritation, pain and rash of the female genitalia; dysmenorrhea; menorrhagia; metrorrhagia.

Musculoskeletal System: Arthralgia, myalgia.

Nervous System: Seizures, anxiety, cognitive change, depression, dream abnormality, euphoria, hallucinations, paresthesia, syncope, vertigo, tremor, confusion.

Nutritional/Metabolic: Thirst, weight loss.

Respiratory System: Respiratory arrest, cough, rhinorrhea.

Skin/Hypersensitivity: Angioedema, diaphoresis, urticaria, vasculitis.

Special Senses: Decreased hearing acuity, tinnitus and photophobia.

Urinary System: Dysuria, urinary frequency and retention.

The following laboratory abnormalities appeared in ≥1% of patients receiving multiple doses of ofloxacin. It is not known whether these abnormalities were caused by the drug or the underlying conditions being treated.

Hematopoietic: Anemia, leukopenia, leukocytosis, neutropenia, neutrophilia, increased band forms, lymphocytopenia, eosinophilia, lymphocytosis, thrombocytopenia, thrombocytosis, elevated ESR.

Hepatic: Elevated: Alkaline phosphatase, AST (SGOT), ALT (SGPT).

Serum Chemistry: Hyperglycemia, hypoglycemia, elevated creatinine, elevated BUN.

Urinary: Glucosuria, proteinuria, alkalinuria, hyposthenuria, hematuria, pyuria.

Post-Marketing Adverse Events: Additional adverse events, regardless of relationship to drug, reported from worldwide marketing experience with quinolones, including ofloxacin: Clinical: Cardiovascular System: Cerebral thrombosis, pulmonary edema, tachycardia, hypotension/shock, syncope, Torsades de pointes.

Endocrine/Metabolic: Hyper- or hypoglycemia, especially in diabetic patients on insulin or oral hypoglycemic agents.

Gastrointestinal System: Hepatic dysfunction including: Hepatic necrosis, jaundice (cholestatic or hepatocellular), hepatitis; intestinal perforation; hepatic failure (including fatal cases); pseudomembranous colitis (the onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment), gastrointestinal hemorrhage; hiccough, painful oral mucosa, pyrosis.

Genital/Reproductive System: Vaginal candidiasis.

Hematopoietic: Anemia, including hemolytic and aplastic; hemorrhage, pancytopenia, agranulocytosis, leukopenia, reversible bone marrow depression, thrombocytopenia, thrombotic thrombocytopenic purpura, petechiae, ecchymosis/bruising.

Musculoskeletal: Tendinitis/rupture; weakness; rhabdomyolysis.

Nervous System: Nightmares; suicidal thoughts or acts, disorientation, psychotic reactions, paranoia; phobia, agitation, restlessness, aggressiveness/hostility, manic reaction, emotional lability; peripheral neuropathy, ataxia, incoordination; possible exacerbation of: Myasthenia gravis and extrapyramidal disorders; dysphasia, lightheadedness.

Respiratory System: Dyspnea, bronchospasm, allergic pneumonitis, stridor.

Skin/Hypersensitivity: Anaphylactic (-toid) reactions/shock; purpura, serum sickness, erythema multiforme/Stevens-Johnson syndrome, erythema nodosum, exfoliative dermatitis, hyperpigmentation, toxic epidermal necrolysis, conjunctivitis, photosensitivity/phototoxicity reaction, vesiculobullous eruption.

Special Senses: Diplopia, nystagmus, blurred vision, disturbances of: Taste, smell, hearing and equilibrium, usually reversible following discontinuation.

Urinary System: Anuria, polyuria, renal calculi, renal failure, interstitial nephritis, hematuria.

Laboratory: Hematopoietic: Prolongation of prothrombin time.

Serum Chemistry: Acidosis, elevation of serum triglycerides, cholesterol, potassium, liver function tests including GGTP, LDH and bilirubin.

Urinary: Albuminuria, candiduria.

In reported clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with other quinolones. The relationship of the drugs to these events is not presently established.

Other reported adverse events includes fungal infection, enterocolitis (sometimes haemorrhagic), anorexia, paraesthesia, unsteady gait, increase in liver enzymes and/or bilirubin, disturbances of kidney function, acute interstitial nephritis, or an increase in serum creatinine, which may progress to acute renal failure.

Crystalluria and cylindruria have been reported with other quinolones.

Ofloxacin (Dermikem OC) OD: The overall frequency of adverse reactions from the clinical database is about 7%. The commonest events involved the gastrointestinal system (about 5%) and the nervous system (about 2%). The following provides a tabulation based on post-marketing experience with ofloxacin where occasional represents a frequency of 0.1-1%, rare <0.1%, very rare <0.01% and isolated cases <0.01%.

Digestive and Liver Side Effects: Occasional: Nausea and vomiting, diarrhoea, abdominal pain, gastric symptoms, (diarrhoea may sometimes be a symptom of enterocolitis which may, in some cases, be haemorrhagic). Rare: Loss of appetite, increase in liver enzymes and/or bilirubin. Very Rare: Cholestatic jaundice, hepatic or severe liver damage may develop. A particular form of enterocolitis that can occur with antibiotics is pseudomembranous colitis (in most cases due to Clostridium difficile). Even if Clostridium difficile is only suspected, administration of ofloxacin should be discontinued immediately and appropriate treatment given. Drugs that inhibit peristalsis should not be administered in such cases.

Central Nervous System: Occasional: Headache, dizziness, sleep disorders, restlessness. Rare: Confusion, nightmares, anxiety, depression, hallucinations and psychotic reactions, drowsiness, unsteady gait and tremor (due to disorders of muscular coordination), neuropathy, numbness and paraesthesiae or hyperaesthesiae, visual disturbances, disturbances of taste and smell (including, in exceptional cases, loss of function) extrapyramidal symptoms. Very Rare: Convulsions, hearing disorders (including, in exceptional cases, loss of hearing). These reactions have occurred in some patients after the 1st dose of ofloxacin; in such cases, discontinue treatment immediately.

Cardiovascular System: Tachycardia and a temporary decrease in blood pressure have been reported. Rare: Circulatory collapse (due to pronounced drop in blood pressure).

Haematological Side Effects: Very Rare: Anaemia, eosinophilia, reversible neutropenia, leucopenia (including agranulocytosis), thrombocytopenia, pancytopenia. Only in some cases are these due to bone marrow depression. In very rare cases, haemolytic anaemias may develop.

Renal Side Effects: Rare: Disturbances of kidney function. Isolated Cases: Acute interstitial nephritis, or an increase in serum creatinine, which may progress to acute renal failure. Allergic and Skin Side Effects: Occasional: Skin rash, itching. Very Rare: Rash on exposure to strong sunlight, other severe skin reactions, hypersensitivity reactions, immediate or delayed, usually involving the skin (eg, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome and vasculitis) may occur. In exceptional circumstances, vasculitis can lead to skin lesions including necrosis and may also involve internal organs. There are rarely other signs of anaphylaxis eg, tachycardia, fever, dyspnoea, shock, angioneurotic oedema, vasculitic reactions, eosinophilia. In such cases, treatment should be discontinued immediately and where appropriate, supportive treatment given.

Isolated Cases: Pneumonitis.

Other Side Effects: Rare: Malaise. Very Rare: Excessive rise or fall in blood sugar levels, weakness, joint and muscle pains (in isolated cases, these may be symptoms of rhabdomyolysis). Isolated Cases: Tendon discomfort including inflammation and rupture of tendons (eg, the Achilles tendon) particularly in patients treated concurrently with corticosteroids. In the event of signs of inflammation of a tendon, treatment with ofloxacin must be stopped immediately and appropriate treatment must be initiated for the affected tendon.

The possibility cannot be ruled out that ofloxacin may trigger an attack of porphyria in predisposed patients.

Except in very rare instances (eg, isolated cases of smell, taste and hearing disorders), the adverse effects observed subsided after discontinuation of ofloxacin.

Laboratory Value Alterations: Serum Alkaline Phosphatase, SGOT, SGPT and Lactate Dehydrogenase: Values may be increased during ofloxacin treatment.

Urinary Opiates and Porphyrins: False positive results may occur.

What is the most important information I should know about Ofloxacin (Dermikem OC)?

Ofloxacin (Dermikem OC) contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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You should not use this medication if you have a history of myasthenia gravis, or if you are allergic to ofloxacin or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and others.

Before taking ofloxacin, tell your doctor if you have kidney or liver disease, joint problems, myasthenia gravis, seizures or epilepsy, diabetes, low levels of potassium in your blood (hypokalemia), or a personal or family history of Long QT syndrome.

Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 2 hours before or after you take ofloxacin. These other medicines can make ofloxacin much less effective when taken at the same time.

Ofloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking ofloxacin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.

Do not share this medication with another person (especially a child), even if they have the same symptoms you have.

Side effects of Ornidazole (Dermikem OC) in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.

Somnolence, headache, nausea, vomiting, dizziness, tremor, rigidity, poor coordination, seizures, tiredness, vertigo, temporary loss of consciousness and signs of sensory or mixed peripheral neuropathy, taste disturbances, abnormal LFTs, skin reactions.

Ornidazole (Dermikem OC) contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.

Hypersensitivity to Ornidazole (Dermikem OC) or to other nitroimidazole derivatives.

What are the possible side effects of Terbinafine (Dermikem OC)?

Get emergency medical help if you have signs of an allergic reaction to Terbinafine (Dermikem OC): hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people taking Terbinafine (Dermikem OC) have developed severe liver damage leading to liver transplant or death. It is not clear whether Terbinafine (Dermikem OC) actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking Terbinafine (Dermikem OC).

Call your doctor at once if you have symptoms of liver damage, such as nausea, upper stomach pain, vomiting, loss of appetite, tiredness, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.

Also call your doctor if you have:

Common Terbinafine (Dermikem OC) side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Terbinafine (Dermikem OC) in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most frequently reported adverse events observed in the 3 US/Canadian placebo-controlled trials are listed in the table below. The adverse events reported encompass gastrointestinal symptoms (including diarrhea, dyspepsia, and abdominal pain), liver test abnormalities, rashes, urticaria, pruritus, and taste disturbances. Changes in the ocular lens and retina have been reported following the use of Terbinafine (Dermikem OC) Tablets in controlled trials. The clinical significance of these changes is unknown. In general, the adverse events were mild, transient, and did not lead to discontinuation from study participation.

Adverse Event Discontinuation
Terbinafine (Dermikem OC) Tablets (%)

n=465

Placebo (%)

n=137

Terbinafine (Dermikem OC) Tablets (%)

n=465

Placebo (%)

n=137

Headache 12.9 9.5 0.2 0.0
Gastrointestinal Symptoms:
Diarrhea 5.6 2.9 0.6 0.0
Dyspepsia 4.3 2.9 0.4 0.0
Abdominal Pain 2.4 1.5 0.4 0.0
Nausea 2.6 2.9 0.2 0.0
Flatulence 2.2 2.2 0.0 0.0
Dermatological Symptoms:
Rash 5.6 2.2 0.9 0.7
Pruritus 2.8 1.5 0.2 0.0
Urticaria 1.1 0.0 0.0 0.0
Liver Enzyme Abnormalities* 3.3 1.4 0.2 0.0
Taste Disturbance 2.8 0.7 0.2 0.0
Visual Disturbance 1.1 1.5 0.9 0.0
*Liver enzyme abnormalities ≥ 2x the upper limit of normal range.

Postmarketing Experience

The following adverse events have been identified during postapproval use of Terbinafine (Dermikem OC) Tablets. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders: Pancytopenia, agranulocytosis, severe neutropenia, thrombocytopenia, anemia

Immune system disorders: Serious hypersensitivity reactions e.g., angioedema and allergic reactions (including anaphylaxis), precipitation and exacerbation of cutaneous and systemic lupus erythematosus, serum sickness-like reaction

Psychiatric disorders: Anxiety and depressive symptoms independent of taste disturbance have been reported with use of Terbinafine (Dermikem OC) Tablets. In some cases, depressive symptoms have been reported to subside with discontinuance of therapy and to recur with reinstitution of therapy.

Nervous system disorders: Cases of taste disturbance, including taste loss, have been reported with the use of Terbinafine (Dermikem OC) Tablets. It can be severe enough to result in decreased food intake, weight loss, anxiety, and depressive symptoms. Cases of smell disturbance, including smell loss, have been reported with the use of Terbinafine (Dermikem OC) Tablets. Cases of paresthesia and hypoesthesia have been reported with the use of Terbinafine (Dermikem OC) Tablets.

Eye disorders: Visual field defects, reduced visual acuity

Ear and labyrinth disorders: Hearing impairment, vertigo, tinnitus

Vascular disorders: Vasculitis

Gastrointestinal disorders: Pancreatitis, vomiting

Hepatobiliary disorders: Cases of liver failure some leading to liver transplant or death, idiosyncratic and symptomatic hepatic injury. Cases of hepatitis, cholestasis, and increased hepatic enzymes have been seen with the use of Terbinafine (Dermikem OC) Tablets.

Skin and subcutaneous tissue disorders: Serious skin reactions [e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome], acute generalized exanthematous pustulosis, psoriasiform eruptions or exacerbation of psoriasis, photosensitivity reactions, hair loss

Musculoskeletal and connective tissue disorders: Rhabdomyolysis, arthralgia, myalgia

General disorders and administration site conditions: Malaise, fatigue, influenza-like illness, pyrexia

Investigations: Altered prothrombin time (prolongation and reduction) in patients concomitantly treated with warfarin and increased blood creatine phosphokinase have been reported

What is the most important information I should know about Terbinafine (Dermikem OC)?

Terbinafine (Dermikem OC) contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.

Before using terbinafine, tell your doctor if you have liver or kidney disease, or an autoimmune disorder such as lupus or psoriasis.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Terbinafine will not treat a viral infection such as the common cold or flu.

Some people taking terbinafine have developed severe liver damage leading to liver transplant or death. It is not clear whether terbinafine actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking terbinafine.

Call your doctor at once if you have symptoms of liver damage, such as nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.

To be sure this medicine is not causing harmful effects, your blood may need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

It may take several months for your nails to return to their normal appearance after your treatment with terbinafine.



References

  1. DailyMed. "TERBINAFINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DailyMed. "OFLOXACIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  3. DTP/NCI. "Ornidazole: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).

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The results of a survey conducted on ndrugs.com for Dermikem OC are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Dermikem OC. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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