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| Product NDC Code | 82160-124 | ||||||
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| Drug Name | Tacrus |
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| Type | Brand | ||||||
| Pharm Class | Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OINTMENT | ||||||
| RxCUI drug identifier | 314266 | ||||||
| Labeler Name | Pella Pharmaceuticals Co. Ltd | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Tacrus
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Overdosage If you accidentaly swallow some ointment If you accidentally swallow the ointment, consult your doctor or pharmacist as soon as possible. Do not try to induce Vomiting. If you forget to use Tacrus ® If you forget to apply the ointment at the scheduled time, do it as soon as you remember and then continue as before. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Possible Side Effects Like all medicines, Tacrus ® can cause side effects, although not everybody gets them. Very common (probably affecting more than 1 in 10): burning sensation and itching; these symptoms are usually mild to moderate and generally go away within one week of using Tacrus ® . Common (probably affecting up to 1 in 10): Redness, feeling of warmth, pain, increased skin sensitivity (especially to hot and cold) skin tingling, rash, local skin infection regardless of specific cause including but not limited to: inflamed or infected hair follicles,cold sores,generalized herpes simplex infections,facial flushing or skin irritation after drinking alcohol is also common. Uncommon (probably affecting less than 1 in 100): acne. Following twice-weekly treatment application site infections have been reported in children and adults, impetigo, a superficial bacterial skin infection that usually produces blisters or sores on the skin,has been reported in children. Rosaceae (facial redness), Rosaceae- like dermatitis and oedema at the application site has been reported during post marketing experience. Since commercial availability a very small number of people who have used Tacrolimus ointment have had malignancies (for example, skin and lymphoma). However a link to Tacrolimus ointment has not been confirmed or refuted on the available evidence so far. If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
Tacrus Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.Drug Interactions Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. You may use moisturizing creams and lotions during treatment with Tacrus® but these products should not be used within two hours of applying Tacrus ® . The use of Tacrus ® at the same time as other preparations to be used on the skin or while taking oral corticosteroids (e.g. cortisone) or medicines which affect the immune system has not been studied. Using Tacrus ® with food and drink While using Tacrus ® , drinking alcohol may cause the skin or face to become flushed or red and feel hot.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.Contraindications If you are allergic (hypersensitive) to tacrolimus or any of other ingredients of Tacrus or to macrolide anttbiotics (e.g. azithromycin, clarithromycin, erythromycin). Tacrolimus 0.03% is not approved in children younger than 2 years of age. Therefore it should not be used in this age group. Please consult your doctor. Tacms ® 0.1 % ointment is not approved for children younger than 16 years of age. Therefore it should not be used in this age group. Please consult your doctor. The effect of treatment with Tacrolimus on the developing immune system in children, especially the young, has not been established. The safety of using Tacrus ® for a long time is not known. A very small number of people who have used Tacrolimous ointment have had malignancies (for example skin or lymphoma) however a link to Tacrolimus ointment treatmert has not been shown. Avoid exposing the skin to long periods of sunlight or artificial sunlight such as tanning beds. If you spend time outdoors after applying Tacrus ® use sunscreen and wear loose fitting clothing that protects the skin from the sun. In addition, ask your doctor for advice on other appropriate sun protection methods. If you are prescribed light therapy, inform your doctor that you are using Tacrus ® as it is not recommended to use Tacrolimus and light therapy at the same time. If your doctor tells you to use Tacrus ® twice weekly to keep your atopic dermatitis cleared, your condition should be reviewed by your doctor at least every 12 months, even if it remains under control. In children, maintenance treatment should be suspended after 12 months, to assess whether the need for continued treatment still exists.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Dosage and Administration Always use Tacrus ® exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Apply Tacrus ® as thin layer to affected areas of your skin. Tacrus ® may be used on most parts of the body, including the face and the neck and in the creases of your elbows and knees. Avoid using the ointment inside your nose or mouth or in your eyes. If the ointment gets on any of these areas, it should be thoroughly wiped off and/or rinsed off with water. Do not cover the skin being treated with bandages or wraps. Wash your hands after applying Tacrus ® unless your hands are also being treated. Before applying Tacrus ® after a bath or shower, be sure your skin is completely dry. Children (2 years of age and older): Apply Tacrolimus 0.03% ointment twice a day for up to three weeks, once in the morning and once in the evening. Afterwards the ointment should be used once a day on each affected region of the skin until the eczema has gone away. Adults (16 years of agc and older): Two strengths of Tacrolimus (0.03% and 0.1% ointment) are available for adults patients (16 years of age and older). Your doctor will decide which strength is best for you. Usually, treatment is started with Tacrus ® 0.1% ointment twice a day, once in the morning and once in the evening, until the eczema has cleared. Depending on the response of your eczema your doctor will decide if the frequency of application can be reduced or the lower strength, Tacrolimus 0.03% ointment, can be used. Treat each affected region of your skin until the eczema has gone away. Improvement is usually seen within one week. If you do not see any improvement after two weeks, see your doctor about other possible treatments. You may be told by your doctor to use Tacrus ® 0.1% ointment twice weekly once your atopic dermatitis has cleared or almost cleared (Tacrolimus 0.03% for children and Tacrs ® 0.1% for adults). Tacrus ® 0.1% ointment should be applied once a day twice weekly (e.g. Monday and Thursday) to areas of your body commonly affected by atopic dermatitis. There should be 2-3 days without Tacrus ® treatment between applications. If symptoms reappear you should use Tacrus ® twice daily as outlined above and arrange to see your doctor to review your treatment.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Indications The active substance of Tacrus ® , tacrolimus monohydrate, is an immune-modulating agent. Tacrus ® 0.03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids and in children (2 years of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids. Tacrus ® 0.1 % ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Once moderate to severe atopic dermatitis is cleared or almost cleared after up to 6 weeks treatment of a flare, and if you are experiencing frequent flares (i.e. 4 oc more per year), it may be possible to prevent flares coming back or prolong the time you are free from flares by using Tacrus ® 0.1% ointment twice weekly. In atopic dermatitis, an over-reaction of the skin's immune system causes skin inflammation (itchiness, redness, dryness). Tacrus ® alters the abnormal immune response and relieves the skin inflammation and the itch.
Spl product data elements
Usually a list of ingredients in a drug product.Tacrus Tacrolimus TACROLIMUS TACROLIMUS ANHYDROUS
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Secondary Package 10 g Secondary Package
Secondary Package 30 g Secondary Package
Primary Package 30 g Primary Package
Primary Package 10 g Primary Package
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy Don't use Tacrus ® if you are pregnant. Ask your doctor or pharmcist before taking any medicine.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.How supplied 10 g packs. 30 g packs.
Storage and handling
Information about safe storage and handling of the drug product.Storage Do not store above 25 °C. Keep out of the reach and sight of children. Do not use Tacrus ® after the expiry date which is stated on the tube and carton after Exp. The expiry date refers to the last day of that month.
General precautions
Information about any special care to be exercised for safe and effective use of the drug.THIS IS A MEDICAMENT Medicament is a product which affects your health and its consumption contrary to instructions is dangerous for you. Strictly follow the doctor's prescription, the method of use and the instruction of the pharmacist who sold the medicament. The doctor and the pharmacist are experts in medicine, its benefits and risks. Do not by yourself interrupt the period of treatment prescribed for you. Do not repeat the same prescription without consulting your doctor. Keep medicament out of reach of children.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.Precautions while taking Tacrus ® Tell your doctor if you: Have liver failuer . Have any skin malignancies (tumors) or if you have a weakened immnne system (immuno-compromised) whatever the cause. Have inherited skin barrier disease such as Netherton's syndrome, lamellar ichthyosis (extensive scaling of the skin due to a thickening of the outer layer of the skin), or if you suffer from generalized erythroderma (inflammatory reddening and scalling of the entire skin). A cutaneous Graft Versus Host Disease (an immune reaction of the skin which is a common complication in patients who have undergone a bone marrowtransplant). Have swollen lymph nodes at initiation of treatment. If your lymph nodes become swollen during treatment with Tacrus ® , consult your doctor. Have infected lesions . Do not apply the ointment to infected lesions. Notice any change to the appearance of your skin, please inform your physician. Lactation Don't use Tacrus ® if you are breast-feeding. Ask your doctor or pharmacist before taking any medicine. Pregnancy Don't use Tacrus ® if you are pregnant. Ask your doctor or pharmcist before taking any medicine.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API