Tacrus
Tacrolimus
Pella Pharmaceuticals Co. Ltd
Human Prescription Drug
NDC 82160-124Tacrus also known as Tacrolimus is a human prescription drug labeled by 'Pella Pharmaceuticals Co. Ltd'. National Drug Code (NDC) number for Tacrus is 82160-124. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Tacrus drug includes Tacrolimus - 30 mg/30g . The currest status of Tacrus drug is Active.
Drug Information:
| Drug NDC: | 82160-124 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Tacrus |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Tacrolimus |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pella Pharmaceuticals Co. Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | TACROLIMUS - 30 mg/30g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 11 Dec, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Pella Pharmaceuticals Co. Ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 314266
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | WM0HAQ4WNM
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Calcineurin Inhibitor Immunosuppressant [EPC]
Calcineurin Inhibitors [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 82160-124-01 | 1 TUBE in 1 CARTON (82160-124-01) / 30 g in 1 TUBE | 11 Dec, 2014 | N/A | No |
| 82160-124-02 | 1 TUBE in 1 CARTON (82160-124-02) / 10 g in 1 TUBE | 11 Dec, 2014 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Tacrus tacrolimus tacrolimus tacrolimus anhydrous
Drug Interactions:
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.
Indications and Usage:
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 ato
Read more...pic 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.
General Precautions:
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.
Dosage and Administration:
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 th
Read more...e 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.
Contraindications:
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.
Adverse Reactions:
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 (facia
Read more...l 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.
Drug Interactions:
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.
Use in Pregnancy:
Pregnancy don't use tacrus ® if you are pregnant. ask your doctor or pharmcist before taking any medicine.
Overdosage:
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.
How Supplied:
How supplied 10 g packs. 30 g packs.
Package Label Principal Display Panel:
Secondary package 10 g secondary package 10 g
Secondary package 30 g secondary package 30 g
Primary package 30 g primary package 30 g
Primary package 10 g primary package 10 g