Dermikem OC Side effects

• Side effects of Clobetasol (Dermikem OC) in details
• Clobetasol (Dermikem OC) contraindications
• Side effects of Ofloxacin (Dermikem OC) in details
• Ofloxacin (Dermikem OC) contraindications
• Side effects of Ornidazole (Dermikem OC) in details
• Ornidazole (Dermikem OC) contraindications
• Side effects of Terbinafine (Dermikem OC) in details
• Terbinafine (Dermikem OC) contraindications
• Dermikem OC reviews

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

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

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) is for external use only. Do not get it in your eyes, nose, or mouth; on your lips; or near your genital area. If you get it in any of these areas, rinse right away with cool water.
• Do NOT use more than the recommended dose or use for longer than 2 weeks without checking with your doctor.
• If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor.
• Talk with your doctor before you use any other medicines or cleansers on your skin.
• Do not use Clobetasol (Dermikem OC) for other skin conditions at a later time.
• Clobetasol (Dermikem OC) has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid (eg, hydrocortisone) in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Tell your doctor or dentist that you use Clobetasol (Dermikem OC) before you receive any medical or dental care, emergency care, or surgery.
• Check with your doctor before you receive any vaccination while you are using Clobetasol (Dermikem OC).
• Serious side effects may occur if too much of Clobetasol (Dermikem OC) is absorbed through the skin. This may be more likely to occur if you use Clobetasol (Dermikem OC) over a large area of the body. It may also be more likely if you wrap or bandage the area after you apply Clobetasol (Dermikem OC). The risk is greater in children. Do not use more than the prescribed dose. Contact your doctor right away if you develop unusual weight gain (especially in the face), muscle weakness, increased thirst or urination, confusion, unusual drowsiness, severe or persistent headache, or vision changes. Discuss any questions or concerns with your doctor.
• Clobetasol (Dermikem OC) is flammable. Do not store near fire or an open flame. Avoid fire, open flame, or smoking during and immediately after use.
• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Clobetasol (Dermikem OC).
• Caution is advised when using Clobetasol (Dermikem OC) in CHILDREN older than 12 years old; they may be more sensitive to its effects.
• Clobetasol (Dermikem OC) should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Clobetasol (Dermikem OC) while you are pregnant. It is not known if Clobetasol (Dermikem OC) is found in breast milk after topical use. If you are or will be breast-feeding while you use Clobetasol (Dermikem OC), check with your doctor. Discuss any possible risks to your baby.

Clobetasol (Dermikem OC) contraindications

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:

• severe stomach pain, diarrhea that is watery or bloody;

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• muscle pain or weakness;

• a seizure (convulsions);

• sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, easy bruising or bleeding, pale skin;

• signs of tendon rupture - sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions);

• nerve symptoms - numbness, weakness, tingling, burning, pain, or being more sensitive to temperature, light touch, or the sense of your body position;

• changes in mood or behavior - depression, confusion, hallucinations, paranoia, tremors, feeling restless or anxious, unusual thoughts or behavior, insomnia, nightmares;

• liver problems - upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• increased pressure inside the skull - severe headaches, ringing in your ears, vision problems, pain behind your eyes; or

• severe skin reaction - skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Ofloxacin (Dermikem OC) side effects may include:

• nausea, constipation, diarrhea;

• dizziness; or

• headache.

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

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) may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Ofloxacin (Dermikem OC) with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Ofloxacin (Dermikem OC) may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Ofloxacin (Dermikem OC). Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Diabetes patients - Ofloxacin (Dermikem OC) may affect your blood sugar when taken along with insulin or other medicines for diabetes. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Tell your doctor or dentist that you take Ofloxacin (Dermikem OC) before you receive any medical or dental care, emergency care, or surgery.
• Ofloxacin (Dermikem OC) only works against bacteria; it does not treat viral infections (eg, the common cold).
• Long-term or repeated use of Ofloxacin (Dermikem OC) may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• If you experience pain or inflammation, or rupture a tendon during or shortly after taking ofloxacin, contact your health care provider immediately.
• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
• Nerve problems in the arms, hands, legs, or feet can happen in people taking Ofloxacin (Dermikem OC). These nerve problems can happen soon after Ofloxacin (Dermikem OC) is started and may be permanent. Call your doctor right away if you have symptoms or nerve problems (eg, not able to handle heat or cold; decreased sensation of touch; unusual burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet).
• Be sure to use Ofloxacin (Dermikem OC) for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Lab tests, including kidney function, may be performed while you use Ofloxacin (Dermikem OC). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Ofloxacin (Dermikem OC) with caution in the ELDERLY; they may be more sensitive to its effects (eg, tendon problems), especially if they take corticosteroids (eg, prednisone). They may also be more sensitive to other effects (eg, irregular heartbeat).
• Ofloxacin (Dermikem OC) should not be used in CHILDREN younger than 18 years; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Ofloxacin (Dermikem OC) while you are pregnant. Ofloxacin (Dermikem OC) is found in breast milk. Do not breast-feed while taking Ofloxacin (Dermikem OC).

Ofloxacin (Dermikem OC) contraindications

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

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

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:

• changes in your sense of taste or smell;

• depressed mood, sleep problems, lack of interest in daily activity, feeling anxious or restless;

• fever, flu symptoms, swollen glands, mouth sores;

• chest pain, fast heart rate, feeling short of breath;

• swelling, rapid weight gain, little or no urinating;

• new or worsening cough, trouble breathing;

• skin sores, butterfly-shaped skin rash on your cheeks and nose (worsens in sunlight);

• weight loss due to taste changes or loss of appetite; or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Terbinafine (Dermikem OC) side effects may include:

• diarrhea, vomiting, stomach pain;

• fever;

• stuffy nose, cough; or

• headache.

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

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.

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)?

• If you experience dizziness while taking Terbinafine (Dermikem OC), use caution. Do not drive or perform other possibly unsafe tasks.
• Terbinafine (Dermikem OC) only works against fungal infections; it does not treat bacterial or viral infections (eg, the common cold).
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Be sure to use Terbinafine (Dermikem OC) for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Very bad skin reactions (eg, Stevens-Johnson syndrome/toxic epidermal necrolysis) that include skin rash with or without liver, lung, kidney, and/or heart problems have occurred in patients taking Terbinafine (Dermikem OC). These reactions can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have red, swollen, blistered, or peeling skin; fever; red or irritated eyes; sores in your mouth, throat, nose, or eyes; or swollen lymph glands (with or without other unusual side effects).
• Terbinafine (Dermikem OC) may lower the ability of your body to fight infection. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Tell your doctor or dentist that you take Terbinafine (Dermikem OC) before you receive any medical or dental care, emergency care, or surgery.
• Before using Terbinafine (Dermikem OC), tell your doctor if you take a medicine that contains caffeine or if you consume large amounts of food or drink that contain caffeine (eg, coffee, tea, cocoa, cola, chocolate).
• Taste changes (eg, taste loss) or changes in smell (eg, loss of smell) have been reported in patients taking Terbinafine (Dermikem OC). These effects may resolve after you stop taking Terbinafine (Dermikem OC), but may last for a long time (eg, more than 1 year), or may be permanent. Tell your doctor right away if you experience changes in smell, taste changes, poor appetite, unwanted weight loss, anxiety, or mood changes (eg, symptoms of depression).
• Terbinafine (Dermikem OC) may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Terbinafine (Dermikem OC). Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Lab tests, including liver function or complete blood cell counts, may be performed while you use Terbinafine (Dermikem OC). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Terbinafine (Dermikem OC) should be used with extreme caution in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Terbinafine (Dermikem OC) can cause harm to the fetus. Do not start taking Terbinafine (Dermikem OC) during pregnancy without talking with your doctor. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using Terbinafine (Dermikem OC) while you are pregnant. Terbinafine (Dermikem OC) is found in breast milk. Do not breast-feed while taking Terbinafine (Dermikem OC).

Terbinafine (Dermikem OC) contraindications

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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Information checked by Dr. Sachin Kumar, MD Pharmacology