Dracanyl Turbuhaler Orifarm may be available in the countries listed below.
Terbutaline sulfate (a derivative of Terbutaline) is reported as an ingredient of Dracanyl Turbuhaler Orifarm in the following countries:
International Drug Name Search
Reducing itching, redness, and swelling associated with skin conditions of the scalp. It may also be used for other conditions as determined by your doctor.
Betamethasone Valerate Foam is a topical corticosteroid. It works by depressing the formation, release, and activity of different cells and chemicals that cause swelling, redness, and itching.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Betamethasone Valerate Foam. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Betamethasone Valerate Foam. Because little, if any, of Betamethasone Valerate Foam is absorbed into the blood, the risk of it interacting with another medicine is low.
Ask your health care provider if Betamethasone Valerate Foam may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Betamethasone Valerate Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Betamethasone Valerate Foam.
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:
Dry skin; mild, temporary stinging when applied.
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 Betamethasone Valerate Foam; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.
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.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.
Store Betamethasone Valerate Foam between 68 and 77 degrees F (20 and 25 degrees C). Avoid temperatures above 120 degrees F (40 degrees C). Store away from heat, moisture, and light. Do not freeze. Keep Betamethasone Valerate Foam out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Betamethasone Valerate Foam. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Bisacodyl Sopharma may be available in the countries listed below.
Bisacodyl is reported as an ingredient of Bisacodyl Sopharma in the following countries:
International Drug Name Search
Acébutolol Zydus may be available in the countries listed below.
Acebutolol hydrochloride (a derivative of Acebutolol) is reported as an ingredient of Acébutolol Zydus in the following countries:
International Drug Name Search
Methopt may be available in the countries listed below.
Hypromellose is reported as an ingredient of Methopt in the following countries:
International Drug Name Search
Monobenzone is the monobenzyl ether of hydroquinone. Monobenzone occurs as a white, almost tasteless crystalline powder, soluble in alcohol and practically insoluble in water.
Chemically, monobenzone is designated as p-(benzyloxy) phenol; the empirical formula is C13H12O2; molecular weight 200.24. The structural formula is:
C13H12O2 200.24
Each gram of Benoquin Cream contains 200 mg of monobenzone USP, in a water-washable base consisting of purified water USP, cetyl alcohol NF, propylene glycol USP, sodium lauryl sulfate NF and white wax NF.
Benoquin Cream 20% is a depigmenting agent whose mechanism of action is not fully understood.
The topical application of monobenzone in animals, increases the excretion of melanin from the melanocytes. The same action is thought to be responsible for the depigmenting effect of the drug in humans. Monobenzone may cause destruction of melanocytes and permanent depigmentation. This effect is erratic and may take one to four months to occur while existing melanin is lost with normal sloughing of the stratum corneum. Hyperpigmented skin appears to fade more rapidly than does normal skin, and exposure to sunlight reduces the depigmenting effect of the drug. The histology of the skin after depigmentation with topical monobenzone is the same as that seen in vitiligo; the epidermis is normal except for the absence of identifiable melanocytes.
Benoquin Cream 20% is indicated for final depigmentation in extensive Vitiligo.
Benoquin Cream 20% is applied topically to permanently depigment normal skin surrounding vitiliginous lesions in patients with disseminated (greater than 50 percent of body surface area) idiopathic vitiligo.
Benoquin Cream 20% is not recommended in freckling; hyperpigmentation caused by photosensitization following the use of certain perfumes (berlock dermatitis); melasma (chloasma) of pregnancy; or hyperpigmentation resulting from inflammation of the skin. Benoquin Cream 20% is not effective for the treatment of cafe-au-lait spots, pigmented nevi, malignant melanoma or pigmentation resulting from pigments other than melanin (e.g.: bile, silver, or artificial pigments).
Benoquin Cream 20% contains a potent depigmenting agent and is not a cosmetic skin bleach. Use of Benoquin Cream 20% is contraindicated in any conditions other than disseminated vitiligo. Benoquin Cream 20% frequently produces irreversible depigmentation, and it must not be used as a substitute for hydroquinone.
Benoquin Cream 20% is also contraindicated in individuals with a history of sensitivity or allergic reactions to this product, or any of its ingredients.
Benoquin Cream 20% is a potent depigmenting agent, not a mild cosmetic bleach. Do not use except for final depigmentation in extensive vitiligo.
Keep this, and all medications out of the reach of children. In case of accidental ingestion, call a physician or a Poison Control Center immediately.
(See Warnings):
Benoquin Cream 20% is for External Use Only. Following therapy with Benoquin Cream 20%, the skin will be sensitive for the rest of the patient’s life. He/she must use sunscreens during exposure to the sun.
Benoquin Cream 20% contains a potent depigmenting agent and is not a cosmetic skin bleach. Use of Benoquin Cream 20% is contraindicated in any conditions other than disseminated vitiligo. Use only for final depigmentation in extensive vitiligo. Areas of normal skin distant to the site of Benoquin Cream 20% application may become depigmented, and irregular, excessive, unsightly, and frequently permanent depigmentation may occur.
No long term studies have been performed to evaluate carcinogenic potential.
Animal reproduction studies have not been conducted with Benoquin Cream 20%. It is also not known whether Benoquin Cream 20% can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. Benoquin Cream 20% should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Benoquin Cream 20% is administered to a nursing woman.
The safety and effectiveness of Benoquin Cream 20% in pediatric patients below the age of 12 years have not been established.
Mild, transient skin irritation and sensitization, including erythematous and eczematous reactions have occurred following topical application of Benoquin Cream 20%. Although those reactions are usually transient, treatment with Benoquin Cream 20% should be discontinued if irritation, a burning sensation, or dermatitis occur. Areas of normal skin distant to the site of Benoquin Cream 20% application frequently have become depigmented, and irregular, excessive, unsightly, and frequently permanent depigmentation has occurred.
A thin layer of Benoquin Cream 20% should be applied and rubbed into the pigmented area two or three times daily, or as directed by physician. Prolonged exposure to sunlight should be avoided during treatment with Benoquin Cream 20%, or a sunscreen should be used.
Depigmentation is usually accomplished after one to four months of Benoquin Cream 20% treatment. If satisfactory results are not obtained after four months of Benoquin Cream 20% treatment, the drug should be discontinued. When the desired degree of depigmentation is obtained, Benoquin Cream 20% should be applied only as often as needed to maintain depigmentation (usually only two times weekly).
Benoquin Cream 20% in 1 1/4 oz. tubes (35.4 g)
(NDC 0187-0380-34).
Benoquin Cream 20% should be stored at 25°C (77°F);
excursion permitted to 15°C - 30°C (59°F - 86°F).
ICN Pharmaceuticals, Inc.
3300 Hyland Ave.
Costa Mesa, CA 92626
(714)545-0100
2393-05 EL
Rev. 8-00
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Generic Name: diazoxide (Oral route)
dye-az-OX-ide
In the U.S.
Available Dosage Forms:
Therapeutic Class: Glucose Regulation, Antihypoglycemic
Chemical Class: Thiazide Related
Diazoxide when taken by mouth is used in the treatment of hypoglycemia (low blood sugar). It works by preventing release of insulin from the pancreas.
Diazoxide is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Infants are more likely to retain (keep) body water because of diazoxide. In some infants, this may lead to certain types of heart problems. Also, a few children who received diazoxide for prolonged periods (longer than 4 years) developed changes in their facial structure.
Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of oral diazoxide in the elderly with use in other age groups.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Take this medicine only as directed by your doctor. Do not take more or less of it than your doctor ordered, and take it at the same time each day.
Follow carefully the special diet your doctor gave you. This is an important part of controlling your condition, and is necessary if the medicine is to work properly.
Test for sugar in your urine or blood with a diabetic urine or blood test kit as directed by your doctor. This is a convenient way to make sure your condition is being controlled, and it provides an early warning when it is not. Your doctor may also want you to test your urine for acetone.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
It is very important that your doctor check your progress at regular visits, especially during the first few weeks of treatment, to make sure that this medicine is working properly.
Before you have any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine.
Do not take any other medicine, unless prescribed or approved by your doctor, since some may interfere with this medicine's effects. This especially includes over-the-counter (OTC) or nonprescription medicine such as that for colds, cough, asthma, hay fever, or appetite control.
Check with your doctor right away if symptoms of high blood sugar (hyperglycemia) occur. These symptoms usually include:
These symptoms may occur if the dose of the medicine is too high, or if you have a fever or infection or are experiencing unusual stress.
Check with your doctor as soon as possible also if these symptoms of low blood sugar (hypoglycemia) occur:
Symptoms of both low blood sugar and high blood sugar must be corrected before they progress to a more serious condition. In either situation, you should check with your doctor immediately.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Stop taking this medicine and get emergency help immediately if any of the following effects occur:
Check with your doctor as soon as possible if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
This medicine may cause a temporary increase in hair growth in some people when it is used for a long time. After treatment with diazoxide has ended, normal hair growth should return.
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Proglycem side effects (in more detail)
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
Penbeta may be available in the countries listed below.
Phenoxymethylpenicillin potassium (a derivative of Phenoxymethylpenicillin) is reported as an ingredient of Penbeta in the following countries:
International Drug Name Search
Penciclovir-Novartis may be available in the countries listed below.
Penciclovir is reported as an ingredient of Penciclovir-Novartis in the following countries:
International Drug Name Search
Vidaza 25 mg/ml powder for suspension for injection
Each vial contains 100 mg azacitidine. After reconstitution, each ml suspension contains 25 mg azacitidine.
For a full list of excipients, see section 6.1.
Powder for suspension for injection.
White lyophilised powder.
Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with:
• intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),
• chronic myelomonocytic leukaemia (CMML) with 10-29 % marrow blasts without myeloproliferative disorder,
• acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification.
Vidaza treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic agents. Patients should be premedicated with anti-emetics for nausea and vomiting.
Posology
The recommended starting dose for the first treatment cycle, for all patients regardless of baseline haematology laboratory values, is 75 mg/m2 of body surface area, injected subcutaneously, daily for 7 days, followed by a rest period of 21 days (28-day treatment cycle).
It is recommended that patients be treated for a minimum of 6 cycles. Treatment should be continued as long as the patient continues to benefit or until disease progression.
Patients should be monitored for haematologic response/toxicity and renal toxicities (see section 4.4); a delay in starting the next cycle or a dose reduction as described below may be necessary.
Dose adjustment due to haematological toxicity
Haematological toxicity is defined as the lowest count reached in a given cycle (nadir) if platelets fall below 50.0 x 109/l and/or absolute neutrophil count (ANC) below 1 x 109/l.
Recovery is defined as an increase of cell line(s) where haematological toxicity was observed of at least half of the difference of nadir and the baseline count plus the nadir count (i.e. blood count at recovery
Patients without reduced baseline blood counts (i.e. White Blood Cells (WBC) > 3.0 x 109/l and ANC >1.5 x 109/l, and platelets > 75.0 x 109/l) prior to the first treatment
If haematological toxicity is observed following Vidaza treatment, the next cycle of Vidaza therapy should be delayed until the platelet count and the ANC have recovered. If recovery is achieved within 14 days, no dose adjustment is necessary. However, if recovery has not been achieved within 14 days, the dose should be reduced according to the following table. Following dose modifications, the cycle duration should return to 28 days.
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*Recovery = counts
Patients with reduced baseline blood counts (i.e. WBC < 3.0 x 109/l or ANC < 1.5 x 109/l or platelets < 75.0 x 109/l) prior to the first treatment
Following Vidaza treatment, if the decrease in WBC or ANC or platelets from that prior to treatment is less than 50 %, or greater than 50 % but with an improvement in any cell line differentiation, the next cycle should not be delayed and no dose adjustment made.
If the decrease in WBC or ANC or platelets is greater than 50 % from that prior to treatment, with no improvement in cell line differentiation, the next cycle of Vidaza therapy should be delayed until the platelet count and the ANC have recovered. If recovery is achieved within 14 days, no dose adjustment is necessary. However, if recovery has not been achieved within 14 days, bone marrow cellularity should be determined. If the bone marrow cellularity is > 50 %, no dose adjustments should be made. If bone marrow cellularity is
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Following dose modifications, the cycle duration should return to 28 days.
Special populations
Renal impairment: No formal studies have been conducted in patients with decreased renal function. Patients with severe organ impairment should be carefully monitored for adverse events. No specific modification to the starting dose is recommended in patients with renal impairment (e.g. baseline serum creatinine or blood urea nitrogen [BUN]
Hepatic impairment: No formal studies have been conducted in patients with hepatic impairment (see section 4.4). Patients with severe hepatic organ impairment should be carefully monitored for adverse events. No specific modification to the starting dose is recommended for patients with hepatic impairment prior to starting treatment; subsequent dose modifications should be based on haematology laboratory values. Vidaza is contraindicated in patients with advanced malignant hepatic tumours (see sections 4.3 and 4.4).
Elderly: No specific dose adjustments are recommended for the elderly. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.
Children and adolescents: Vidaza is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
Laboratory tests
Liver function tests, serum creatinine and serum bicarbonate should be determined prior to initiation of therapy and prior to each treatment cycle. Complete blood counts should be performed prior to initiation of therapy and as needed to monitor response and toxicity, but at a minimum, prior to each treatment cycle.
Method of administration
Reconstituted Vidaza should be injected subcutaneously into the upper arm, thigh or abdomen. Injection sites should be rotated. New injections should be given at least 2.5 cm from the previous site and never into areas where the site is tender, bruised, red, or hardened.
After reconstitution, the suspension should not be filtered.
Detailed instructions for the reconstitution and administration procedure for Vidaza are provided in section 6.6.
Known hypersensitivity to the active substance or to any of the excipients.
Advanced malignant hepatic tumours (see section 4.4).
Breastfeeding (see section 4.6).
Haematological toxicity
Treatment with azacitidine is associated with anaemia, neutropenia and thrombocytopenia, particularly during the first 2 cycles (see section 4.8). Complete blood counts should be performed as needed to monitor response and toxicity, but at least prior to each treatment cycle. After administration of the recommended dose for the first cycle, the dose for subsequent cycles should be reduced or its administration delayed based on nadir counts and haematological response (see section 4.2). Patients should be advised to promptly report febrile episodes. Patients and physicians are also advised to be observant for signs and symptoms of bleeding.
Hepatic impairment
No formal studies have been conducted in patients with hepatic impairment. Patients with extensive tumour burden due to metastatic disease have been reported to experience progressive hepatic coma and death during azacitidine treatment, especially in such patients with baseline serum albumin < 30 g/l. Azacitidine is contraindicated in patients with advanced malignant hepatic tumours (see section 4.3).
Renal impairment
Renal abnormalities ranging from elevated serum creatinine to renal failure and death were reported in patients treated with intravenous azacitidine in combination with other chemotherapeutic agents. In addition, renal tubular acidosis, defined as a fall in serum bicarbonate to < 20 mmol/l in association with an alkaline urine and hypokalaemia (serum potassium < 3 mmol/l) developed in 5 subjects with chronic myelogenous leukaemia (CML) treated with azacitidine and etoposide. If unexplained reductions in serum bicarbonate (< 20 mmol/l) or elevations of serum creatinine or BUN occur, the dose should be reduced or administration delayed (see section 4.2).
The patients should be advised to report oliguria and anuria to the health care provider immediately.
Patients with renal impairment should be closely monitored for toxicity since azacitidine and/or its metabolites are primarily excreted by the kidney (see section 4.2).
Cardiac and pulmonary disease
Patients with a history of severe congestive heart failure, clinically unstable cardiac disease or pulmonary disease were excluded from the pivotal clinical study and therefore the safety and efficacy of Vidaza in these patients has not been established.
Based on in vitro data, azacitidine metabolism does not appear to be mediated by cytochrome P450 isoenzymes (CYPs), UDP-glucuronosyltransferases (UGTs), sulfotransferases (SULTs), and glutathione transferases (GSTs); interactions related to these metabolizing enzymes in vivo are therefore considered unlikely.
Clinically significant inhibitory or inductive effects of azacitidine on cytochrome P450 enzymes are unlikely (see section 5.2).
No formal clinical drug interaction studies with azacitidine have been conducted.
Women of childbearing potential / Contraception in males and females
Men and women of childbearing potential must use effective contraception during and up to 3 months after treatment.
Pregnancy
There are no adequate data on the use of azacitidine in pregnant women. Studies in mice have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Based on results from animal studies and its mechanism of action, azacitidine should not be used during pregnancy, especially during the first trimester, unless clearly necessary. The advantages of treatment should be weighed against the possible risk for the foetus in every individual case.
Breastfeeding
It is not known whether azacitidine or its metabolites are excreted in human milk. Due to the potential serious adverse reactions in the nursing child, breastfeeding is contraindicated during azacitidine therapy.
Fertility
There are no human data on the effect of azacitidine on fertility. In animals, adverse effects of azacitidine on male fertility have been documented (see section 5.3). Men should be advised not to father a child while receiving treatment and must use effective contraception during and up to 3 months after treatment. Before starting treatment, male patients should be advised to seek counselling on sperm storage.
No studies of the effects on the ability to drive and use machines have been performed. Patients should be advised that they may experience undesirable effects such as fatigue, during treatment. Therefore, caution should be recommended when driving a car or operating machines.
Adverse reactions considered to be possibly or probably related to the administration of Vidaza have occurred in 97 % of patients.
The most commonly reported adverse reactions with azacitidine treatment were haematological reactions (71.4 %) including thrombocytopenia, neutropenia and leukopenia (usually Grade 3-4), gastrointestinal events (60.6 %) including nausea, vomiting (usually Grade 1-2) or injection site reactions (77.1 %; usually Grade 1-2).
The most common serious adverse reactions (> 2 %) noted from the pivotal study (AZA PH GL 2003 CL 001) and also reported in the supporting studies (CALGB 9221 and CALGB 8921) included febrile neutropenia (8.0 %) and anaemia (2.3 %). Other reported serious adverse reactions included infections such as neutropenic sepsis and pneumonia (some with fatal outcome), thrombocytopenia and haemorrhagic events (e.g. cerebral haemorrhage).
The table below contains adverse reactions associated with azacitidine treatment obtained from clinical studies and post marketing surveillance.
Frequencies are defined as: very common (
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*= rarely fatal cases have been reported
Haematologic adverse reactions
The most commonly reported adverse reactions associated with azacitidine treatment were haematological including thrombocytopenia, neutropenia and leukopenia, and were usually Grade 3 or 4. There is a greater risk of these events occurring during the first 2 cycles, after which they occur with less frequency in patients with restoration of haematological function. Most haematological adverse reactions were managed by routine monitoring of complete blood counts and delaying azacitidine administration in the next cycle, prophylactic antibiotics and/or growth factor support (e.g. G-CSF) for neutropenia and transfusions for anaemia or thromobocytopenia as required.
Infections
Myelosupression may lead to neutropenia and an increased risk of infection. Serious infections such as neutropenic sepsis (0.8 %) and pneumonia (2.5 %) were reported in patients receiving azacitidine, some with a fatal outcome. Infections may be managed with the use of anti-infectives plus growth factor support (e.g. G-CSF) for neutropenia.
Bleeding
Bleeding may occur with patients receiving azacitidine. Serious adverse reactions such as gastrointestinal haemorrhage (0.8 %) and intracranial haemorrhage (0.5 %) have been reported. Patients should be monitored for signs and symptoms of bleeding, particularly those with pre-existing or treatment-related thrombocytopenia.
Hypersensitivity
Serious hypersensitivity reactions (0.25 %) have been reported in patients receiving azacitidine. In case of an anaphylactic-like reaction, treatment with azacitidine should be immediately discontinued and appropriate symptomatic treatment initiated.
Skin and subcutaneous tissue adverse reactions
The majority of skin and subcutaneous adverse reactions were associated with the injection site. None of these adverse reactions led to temporary or permanent discontinuation of azacitidine, or reduction of azacitidine dose in the pivotal study. The majority of adverse reactions occurred during the first 2 cycles and tended to decrease with subsequent cycles. Subcutaneous adverse reactions such as injection site rash/inflammation/pruritus, rash, erythema and skin lesion may require management with concomitant medicinal products, such as antihistamines, corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs).
Gastrointestinal adverse reactions
The most commonly reported gastrointestinal adverse reactions associated with azacitidine treatment included constipation, diarrhoea, nausea and vomiting. These adverse reactions were managed symptomatically with anti-emetics for nausea and vomiting; antidiarrhoeals for diarrhoea, and laxatives and/or stool softeners for constipation.
Renal adverse reactions
Renal abnormalities, ranging from elevated serum creatinine and haematuria to renal tubular acidosis, renal failure and death were reported in patients treated with azacitidine (see section 4.4).
Hepatic adverse reactions
Patients with extensive tumour burden due to metastatic disease have been reported to experience hepatic failure, progressive hepatic coma and death during azacitidine treatment (see section 4.4).
One case of overdose with azacitidine was reported during clinical trials. A patient experienced diarrhoea, nausea, and vomiting after receiving a single intravenous dose of approximately 290 mg/m2, almost 4 times the recommended starting dose.
In the event of overdose, the patient should be monitored with appropriate blood counts and should receive supportive treatment, as necessary. There is no known specific antidote for azacitidine overdose.
Pharmacotherapeutic group: Antineoplastic agent, Pyrimidine analogues; ATC code: L01BC07
Mechanism of action
Azacitidine is believed to exert its antineoplastic effects by multiple mechanisms including cytotoxicity on abnormal haematopoietic cells in the bone marrow and hypomethylation of DNA. The cytotoxic effects of azacitidine may result from multiple mechanisms, including inhibition of DNA, RNA and protein synthesis, incorporation into RNA and DNA, and activation of DNA damage pathways. Non-proliferating cells are relatively insensitive to azacitidine. Incorporation of azacitidine into DNA results in the inactivation of DNA methyltransferases, leading to hypomethylation of DNA. DNA hypomethylation of aberrantly methylated genes involved in normal cell cycle regulation, differentiation and death pathways may result in gene re-expression and restoration of cancer-suppressing functions to cancer cells. The relative importance of DNA hypomethylation versus cytotoxicity or other activities of azacitidine to clinical outcomes has not been established.
Clinical efficacy and safety
The efficacy and safety of Vidaza were studied in an international, multicenter, controlled, open-label, randomised, parallel-group, Phase 3 comparative study (AZA PH GL 2003 CL 001) in patients with: intermediate-2 and high-risk MDS according to the International Prognostic Scoring System (IPSS), refractory anaemia with excess blasts (RAEB), refractory anaemia with excess blasts in transformation (RAEB-T) and modified chronic myelomonocytic leukaemia (mCMML) according to the French American British (FAB) classification system. RAEB-T patients (21-30 % blasts) are now considered to be AML patients under the current WHO classification system. Azacitidine plus best supportive care (BSC) (n = 179) was compared to conventional care regimens (CCR). CCR consisted of BSC alone (n = 105), low-dose cytarabine plus BSC (n = 49) or standard induction chemotherapy plus BSC (n = 25). Patients were pre-selected by their physician to 1 of the 3 CCR prior to randomisation. Patients received this pre-selected regimen if not randomised to Vidaza. As part of the inclusion criteria, patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Patients with secondary MDS were excluded from the study. The primary endpoint of the study was overall survival. Vidaza was administered at a subcutaneous dose of 75 mg/m2 daily for 7 days, followed by a rest period of 21 days (28-day treatment cycle) for a median of 9 cycles (range = 1-39) and a mean of 10.2 cycles. Within the Intent to Treat population (ITT), the median age was 69 years (range 38 to 88 years).
In the ITT analysis of 358 patients (179 azacitidine and 179 CCR), Vidaza treatment was associated with a median survival of 24.46 months versus 15.02 months for those receiving CCR treatment, a difference of 9.4 months, with a stratified log-rank p-value of 0.0001. The hazard ratio for the treatment effect was 0.58 (95 % CI: 0.43, 0.77). The two-year survival rates were 50.8 % in patients receiving azacitidine versus 26.2 % in patients receiving CCR (p < 0.0001).
The survival benefits of Vidaza were consistent regardless of the CCR treatment option (BSC alone, low-dose cytarabine plus BSC or standard induction chemotherapy plus BSC) utilised in the control arm.
When IPSS cytogenetic subgroups were analysed, similar findings in terms of median overall survival were observed in all groups (good, intermediate, poor cytogenetics, including monosomy 7).
On analyses of age subgroups, an increase in median overall survival was observed for all groups (< 65 years,
Vidaza treatment was associated with a median time to death or transformation to AML of 13.0 months versus 7.6 months for those receiving CCR treatment, an improvement of 5.4 months with a stratified log-rank p-value of 0.0025.
Vidaza treatment was also associated with a reduction in cytopenias, and their related symptoms. Vidaza treatment led to a reduced need for red blood cell (RBC) and platelet transfusions. Of the patients in the azacitidine group who were RBC transfusion dependent at baseline, 45.0 % of these patients became RBC transfusion independent during the treatment period, compared with 11.4 % of the patients in the combined CCR groups (a statistically significant (p < 0.0001) difference of 33.6 % (95 % CI: 22.4, 44.6). In patients who were RBC transfusion dependent at baseline and became independent, the median duration of RBC transfusion independence was 13 months in the azacitidine group.
Response was assessed by the investigator or by the Independent Review Committee (IRC). Overall response (complete remission [CR] + partial remission [PR]) as determined by the investigator was 29 % in the azacitidine group and 12% in the combined CCR group (p = 0.0001). Overall response (CR + PR) as determined by the IRC in AZA PH GL 2003 CL 001 was 7 % (12/179) in the azacitidine group compared with 1 % (2/179) in the combined CCR group (p = 0.0113). The differences between the IRC and investigator assessments of response were a consequence of the International Working Group (IWG) criteria requiring improvement in peripheral blood counts and maintenance of these improvements for a minimum of 56 days. A survival benefit was also demonstrated in patients that had not achieved a complete/partial response following azacitidine treatment. Haematological improvement (major or minor) as determined by the IRC was achieved in 49 % of patients receiving azacitidine compared with 29 % of patients treated with combined CCR (p < 0.0001).
In patients with one or more cytogenetic abnormalities at baseline, the percentage of patients with a major cytogenetic response was similar in the azacitidine and combined CCR groups. Minor cytogenetic response was statistically significantly (p = 0.0015) higher in the azacitidine group (34 %) compared with the combined CCR group (10 %).
The pharmacokinetics of azacitidine were studied following single 75 mg/m2 doses given by subcutaneous and intravenous administration.
Absorption
Azacitidine was rapidly absorbed after subcutaneous administration with peak plasma azacitidine concentrations of 750 ± 403 ng/ml occurring at 0.5 h (the first sampling point) after dosing. The absolute bioavailability of azacitidine after subcutaneous relative to intravenous administration was approximately 89 % based on area under the curve (AUC).
Distribution
Following intravenous administration, the mean volume of distribution was 76 ± 26 l, and systemic clearance was 147 ± 47 l/h.
Metabolism
Based on in vitro data, azacitidine metabolism does not appear to be mediated by cytochrome P450 isoenzymes (CYPs), UDP-glucuronosyltransferases (UGTs), sulfotransferases (SULTs), and glutathione transferases (GSTs).
Metabolism of azacitidine is by spontaneous hydrolysis and by deamination mediated by cytidine deaminase. In human liver S9 fractions, formation of metabolites was independent of NADPH implying any metabolism would be catalysed by cytosolic enzymes. An in vitro study of azacitidine with cultured human hepatocytes indicates that at concentrations of 1.0 µM to 100 µM (i.e. up to approximately 30-fold higher than clinically achievable concentrations), azacitidine does not induce cytochrome P450 isoenzymes (CYP) 1A2, 2C19, or 3A4 or 3A5. In studies to assess inhibition of a series of P450 isoenzymes (CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4) incubated with 100 µM azacitidine, IC50 values could not be determined, therefore, enzyme inhibition by azacitidine at clinically achievable plasma concentrations is unlikely.
Excretion
Azacitidine is cleared rapidly from plasma with a mean elimination half-life (t½) after subcutaneous administration of 41 ± 8 minutes. No accumulation occurs after subcutaneous administration of 75 mg/m2 azacitidine once daily for 7 days. Urinary excretion is the primary route of elimination of azacitidine and/or its metabolites. Following intravenous and subcutaneous administration of 14C-azacitidine, 85 and 50 % of the administered radioactivity was recovered in urine respectively, while < 1 % was recovered in faeces.
Special populations
The effects of renal or hepatic impairment (see section 4.2), gender, age, or race on the pharmacokinetics of azacitidine have not been formally studied.
Pharmacogenomics
The effect of known cytidine deaminase polymorphisms on azacitidine metabolism has not been formally investigated.
Azacitidine induces both gene mutations and chromosomal aberrations in bacterial and mammalian cell systems in vitro. The potential carcinogenicity of azacitidine was evaluated in mice and rats. Azacitidine induced tumours of the haematopoietic system in female mice, when administered intraperitoneally 3 times per week for 52 weeks. An increased incidence of tumours in the lymphoreticular system, lung, mammary gland, and skin was seen in mice treated with azacitidine administered intraperitoneally for 50 weeks. A tumorigenicity study in rats revealed an increased incidence of testicular tumours.
Early embryotoxicity studies in mice revealed a 44 % frequency of intrauterine embryonal death (increased resorption) after a single intraperitoneal injection of azacitidine during organogenesis. Developmental abnormalities in the brain have been detected in mice given azacitidine on or before closure of the hard palate. In rats, azacitidine caused no adverse effects when given pre-implantation, but it was clearly embryotoxic during when given during organogenesis. Foetal abnormalities caused during organogenesis included: CNS anomalies (exencephaly/encephalocele), limb anomalies (micromelia, club foot, syndactyly, oligodactyly) and others (micrognathia, gastroschisis, oedema, and rib abnormalities).
Administration of azacitidine to male mice prior to mating with untreated female mice resulted in decreased fertility and loss of offspring during subsequent embryonic and postnatal development. Treatment of male rats resulted in decreased weight of the testes and epididymides, decreased sperm counts, decreased pregnancy rates, an increase in abnormal embryos and increased loss of embryos in mated females (see section 4.4).
Mannitol (E421)
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.3 and 6.6.
Unopened powder vial:
4 years
After reconstitution:
When Vidaza is reconstituted using water for injections that has not been refrigerated, chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 25°C for 45 minutes and at 2°C to 8°C for 8 hours.
The shelf life of the reconstituted medicinal product can be extended by reconstituting with refrigerated (2°C to 8°C) water for injections. When Vidaza is reconstituted using refrigerated (2°C to 8°C) water for injections, the chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 2°C to 8°C for 22 hours.
From a microbiological point of view, the reconstituted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than 8 hours at 2°C to 8°C when reconstituted using water for injections that has not been refrigerated or not longer than 22 hours when reconstituted using refrigerated (2°C to 8°C) water for injections.
This medicinal product does not require any special storage conditions.
For storage conditions of the reconstituted medicinal product, see section 6.3.
Colourless type I 30 ml glass vial sealed with butyl elastomeric stopper and aluminium seal with polypropylene plastic button.
Pack size: 1 vial of 100 mg azacitidine.
Recommendations for safe handling
Vidaza is a cytotoxic medicinal product and, as with other potentially toxic compounds, caution should be exercised when handling and preparing azacitidine suspensions. Procedures for proper handling and disposal of anticancer medicinal products should be applied.
If reconstituted azacitidine comes into contact with the skin, immediately and thoroughly wash with soap and water. If it comes into contact with mucous membranes, flush thoroughly with water.
Reconstitution procedure
Vidaza should be reconstituted with water for injections. The shelf life of the reconstituted medicinal product can be extended by reconstituting with refrigerated (2°C to 8°C) water for injections. Details on storage of the reconstituted product are provided below.
1. The following supplies should be assembled:
• Vial(s) of azacitidine; vial(s) of water for injections; nonsterile surgical gloves;
• Alcohol wipes; 5 ml injection syringe(s) with needle(s).
2. 4 ml of water for injections should be drawn into the syringe, making sure to purge any air trapped within the syringe.
3. The needle of the syringe containing the 4 ml of water for injections should be inserted through the rubber top of the azacitidine vial followed by injection of the water for injections into the vial.
4. Following removal of the syringe and needle, the vial should be vigorously shaken until a uniform cloudy suspension is achieved. After reconstitution each ml of suspension will contain 25 mg of azacitidine (100 mg/4 ml). The reconstituted product is a homogeneous, cloudy suspension, free of agglomerates. The product should be discarded if it contains large particles or agglomerates. Do not filter the suspension after reconstitution since this could remove the active substance. It must be taken into account that filters are present in some adaptors, spikes and closed systems; therefore such systems should not be used for administration of the drug after reconstitution.
5. The rubber top should be cleaned and a new syringe with needle inserted. The vial should then be turned upside down, making sure the needle tip is below the level of the liquid. The plunger should then be pulled back to withdraw the amount of medicinal product required for the proper dose, making sure to purge any air trapped within the syringe. The syringe with needle should then be removed from the vial and the needle disposed of.
6. A fresh subcutaneous needle (recommended 25-gauge) should then be firmly attached to the syringe. The needle should not be purged prior to injection, in order to reduce the incidence of local injection site reactions.
7. If needed (doses over 100 mg) all the above steps for preparation of the suspension should be repeated. For doses greater than 100 mg (4 ml), the dose should be equally divided into 2 syringes (e.g, dose 150 mg = 6 ml, 2 syringes with 3 ml in each syringe).
8. The contents of the dosing syringe must be re-suspended immediately prior to administration. The temperature of the suspension at the time of injection should be approximately 20ºC-25ºC. To re-suspend, vigorously roll the syringe between the palms until a uniform, cloudy suspension is achieved. The product should be discarded if it contains large particles or agglomerates.
Storage of the reconstituted product
For immediate use:
The Vidaza suspension may be prepared immediately before use and the reconstituted suspension should be administered within 45 minutes. If elapsed time is greater than 45 minutes, the reconstituted suspension should be discarded appropriately and a new dose prepared.
For later use:
When reconstituting using water for injections that has not been refrigerated, the reconstituted suspension must be placed in a refrigerator (2°C to 8°C) immediately after reconstitution, and kept in the refrigerator for a maximum of 8 hours. If the elapsed time in the refrigerator is greater than 8 hours, the suspension should be discarded appropriately and a new dose prepared.
When reconstituting using refrigerated (2°C to 8°C) water for injections, the reconstituted suspension must be placed in a refrigerator (2°C to 8°C) immediately after reconstitution, and kept in the refrigerator for a maximum of 22 hours. If the elapsed time in the refrigerator is greater than 22 hours, the suspension should be discarded appropriately and a new dose prepared.
The syringe filled with reconstituted suspension should be allowed up to 30 minutes prior to administration to reach a temperature of approximately 20°C-25°C. If the elapsed time is longer than 30 minutes, the suspension should be discarded appropriately and a new dose prepared.
Calculation of an individual dose
The total dose, according to the body surface area (BSA) can be calculated as follows:
Total dose (mg) = Dose (mg/m2) x BSA (m2)
The following table is provided only as an example of how to calculate individual azacitidine doses based on an average BSA value of 1.8 m2.
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Method of administration
Reconstituted Vidaza should be injected subcutaneously (insert the needle at a 45-90o angle) using a 25-gauge needle into the upper arm, thigh or abdomen.
Doses greater than 4 ml should be injected into two separate sites.
Injection sites should
Bisoprolol/Hydrochlorothiazide Qualimed may be available in the countries listed below.
Bisoprolol fumarate (a derivative of Bisoprolol) is reported as an ingredient of Bisoprolol/Hydrochlorothiazide Qualimed in the following countries:
Hydrochlorothiazide is reported as an ingredient of Bisoprolol/Hydrochlorothiazide Qualimed in the following countries:
International Drug Name Search
DESCRIPTION: BPO 3% and 6% Foaming Cloths are topical preparations containing benzoyl peroxide for use in the treatment of acne vulgaris. Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl peroxide (C14H10O4) is represented by the following chemical structure:
BPO 3% and 6% Foaming Cloths contain, respectively, benzoyl peroxide 3% and 6% as the active ingredient in a cream vehicle containing: cetostearyl alcohol, hydrogenated castor oil, cocamidopropyl betaine, PEG-14M, methyl paraben, mineral oil, purified water, sodium lauryl sulfate, potassium choride, glycolic acid, imidurea, sodium PCA liquid, cornstarch, titanium dioxide, sodium hydroxide, glycerine, dimethyl isosorbide.
CLINICAL PHARMACOLOGY: The mechanism of action of benzoyl peroxide is not totally understood but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. In addition, patients treated with benzoyl peroxide show a reduction in lipids and free fatty acids, and mild desquamation (drying and peeling activity) with simultaneous reduction in comedones and acne lesions. Little is known about the percutaneous penetration, metabolism, and excretion of benzoyl peroxide, although it has been shown that benzoyl peroxide absorbed by the skin is metabolized to benzoic acid and then excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by benzoyl peroxide in humans.
INDICATIONS: BPO 3% and 6% Foaming Cloths are indicated for the topical treatment of acne vulgaris.
CONTRAINDICATIONS: These preparations are contraindicated in patients with a history of hypersensitivity to any of their components.
WARNINGS: When using this product, avoid unnecessary sun exposure and use a sunscreen. FOR EXTERNAL USE ONLY. Keep away from eyes. Keep container tightly closed.
Keep out of reach of children.
PRECAUTIONS: General - For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes.
Information for patients - Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.
Carcinogenesis, Mutagenesis, Impairment of Fertility - Data from several studies employing a strain of mice that are highly susceptible to developing cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown. Benzoyl peroxide has not been found to be mutagenic (Ames Test) and there are no published data indicating it impairs fertility.
PREGNANCY: Teratogenic Effects - Pregnancy Category C. - Animal reproduction studies have not been conducted with benzoyl peroxide. It is not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be used by a pregnant woman only if clearly needed. There are no available data on the effect of benzoyl peroxide on the later growth, development and functional maturation of the unborn child.
NURSING MOTHERS: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.
PEDIATRIC USE: Safety and effectiveness in children have not been established.
ADVERSE REACTIONS:Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.
OVERDOSAGE: If excessive scaling, erythema or edema occurs, the use of these preparations should be discontinued. To hasten resolution of the adverse effects, cool compresses may be used. After symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.
DOSAGE AND ADMINISTRATION: Wash affected areas once or twice daily, or as directed by your physician. Wet face with water. Wet cloth with a little water and work into a full lather. Cleanse face with cloth for 10–20 seconds. Avoid eyes or mucous membranes. Rinse thoroughly and pat dry.
If drying occurs, it may be controlled by rinsing sooner or using less often. Throw away cloth. Do not flush.
HOW SUPPLIED: BPO 3% Foaming Cloths are available in boxes of 60 cloths (3.2g), (NDC 42192-124-60).
BPO 6% Foaming Cloths are available in boxes of 60 cloths (3.2g), (NDC 42192-125-60).
Store at controlled room temperature, 15° - 25°C (59° - 77°F).
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.
MANUFACTURED FOR: Acella Pharmaceuticals, LLC
9005 Westside Parkway
Alpharetta, GA 30009
1 - 800 - 541 - 4802 Rev. 0610
NDC 42192-125-60
BPO 6% Foaming Cloths
Rx only
Net weight 3.2 g each
Acella
Pharmaceuticals, LLC
Contents: benzoyl peroxide USP 6% as an active ingredient in a cream vehicle containing cetostearyl alcohol, hydrogenated castor oil, cocamidopropyl betaine, PEG-14M, methyl paraben, mineral oil, purified water, sodium lauryl sulfate, potassium choride, glycolic acid, imidurea, sodium PCA liquid, cornstarch, titanium dioxide, sodium hydroxide, glycerine, dimethyl isosorbide.
Directions: Wash affecte areas with BPO 6% Foaming cloths once or twice daily, or as directed by your physician.
1. Wet face with water.
2. Wet cloth with a little water and work into a full lather.
3. Cleanse face wuth cloth for 10 - 20 seconds, avoiding eyes and mucous membrances.
4. Rinse thoroughly and pat dry.
5. Discard cloth. Do not flush.
If drying occurs, It may be controlled by rinsing cleanser off sooner or using less often.
Precautions: See Package insert for complete Precautions and Prescribing information. For external use only. Avoid contat with eyes, eyelids, lips ad mucous membranes. If accidental contact occurs, rinse with water, Contact with any colored material (Including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.
Warnings: KEEP OUT OF REACH OF CHILDREN. When using this product, avoid unnecessary sun exposure and use a sunscreen.
Store at 15 Degree centigrade - 25 Degree C (59 Degree centigrade - 77 Degree F).
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Please see package insert for more information.
MANUFACTURED FOR:
Acella Pharmaceuticals, LLC
Alpharetta, GA 30009
1-800-541-4802
Rx Only
60 foaming cloths - Net weight 3.2 g each
Acella
Pharmaceuticals, LLC
NDC 42192-125-60
BPO 6% Foaming Cloths
Contents: benzoyl peroxide USP 6% as an active ingredient in a cream vehicle containing cetostearyl alcohol, hydrogenated castor oil, cocamidopropyl betaine, PEG-14M, methyl paraben, mineral oil, purified water, sodium lauryl sulfate, potassium choride, glycolic acid, imidurea, sodium PCA liquid, cornstarch, titanium dioxide, sodium hydroxide, glycerine, dimethyl isosorbide.
Directions: Wash affecte areas with BPO 6% Foaming cloths once or twice daily, or as directed by your physician.
1. Wet face with water.
2. Wet cloth with a little water and work into a full lather.
3. Cleanse face wuth cloth for 10 - 20 seconds, avoiding eyes and mucous membrances.
4. Rinse thoroughly and pat dry.
5. Discard cloth. Do not flush.
If drying occurs, It may be controlled by rinsing cleanser off sooner or using less often.
Precautions: See Package insert for complete Precautions and Prescribing information. For external use only. Avoid contat with eyes, eyelids, lips ad mucous membranes. If accidental contact occurs, rinse with water, Contact with any colored material (Including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.
Warnings: KEEP OUT OF REACH OF CHILDREN. When using this product, avoid unnecessary sun exposure and use a sunscreen.
Store at 15 Degree centigrade - 25 Degree C (59 Degree centigrade - 77 Degree F).
NDC 42192-125-60
BPO 6% Foaming Cloths
Rx Only
60 foaming cloths - Net weight 3.2 g each
Acella
Pharmaceuticals, LLC
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable.
NOTE: This is not an Orange Book product. No representation is made as to generic status or bioequivalency. Please see package insert for more information.
MANUFACTURED FOR:
Acella Pharmaceuticals, LLC
9005 Westside Parkway
Alpharetta, GA 30009
1-800-541-4802
Rev.0510v1
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 08/18/2010 | ||
| Labeler - Acella Pharmaceuticals, LLC (825380939) |
