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If you are a consumer or patient please visit this version. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Cefdinir capsules contains the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration.
Cefdinir is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0. Cefdinir has the structural formula shown below:.
Cefdinir capsules contain mg of cefdinir and the following inactive ingredients: carboxymethylcellulose calcium; colloidal silicon dioxide; and magnesium stearate.
Oral Bioavailability: Maximal plasma cefdinir concentrations occur 2 to 4 hours postdose following capsule or suspension administration. The magnitude of these reductions is not likely to be clinically significant. Therefore, cefdinir may be taken without regard to food. Cefdinir Capsules: Cefdinir plasma concentrations and pharmacokinetic parameter values following administration of single and mg oral doses of cefdinir to adult subjects are presented in the following table:.
Multiple Dosing: Cefdinir does not accumulate in plasma following once- or twice-daily administration to subjects with normal renal function. The mean volume of distribution Vd area of cefdinir in adult subjects is 0.
Skin Blister: In adult subjects, median range maximal blister fluid cefdinir concentrations of 0. Tonsil Tissue: In adult patients undergoing elective tonsillectomy, respective median tonsil tissue cefdinir concentrations 4 hours after administration of single and mg doses were 0. Lung Tissue: In adult patients undergoing diagnostic bronchoscopy, respective median bronchial mucosa cefdinir concentrations 4 hours after administration of single and mg doses were 0. Respective median epithelial lining fluid concentrations were 0.
CSF: Data on cefdinir penetration into human cerebrospinal fluid are not available. Cefdinir is not appreciably metabolized. Activity is primarily due to parent drug. In healthy subjects with normal renal function, renal clearance is 2. Mean percent of dose recovered unchanged in the urine following and mg doses is Cefdinir clearance is reduced in patients with renal dysfunction see Special Populations: Patients with Renal Insufficiency. Patients with Renal Insufficiency: Cefdinir pharmacokinetics were investigated in 21 adult subjects with varying degrees of renal function.
As a result, plasma cefdinir concentrations were higher and persisted longer in subjects with renal impairment than in those without renal impairment. Hemodialysis: Cefdinir pharmacokinetics were studied in 8 adult subjects undergoing hemodialysis.
Hepatic Disease: Because cefdinir is predominantly renally eliminated and not appreciably metabolized, studies in patients with hepatic impairment were not conducted. It is not expected that dosage adjustment will be required in this population.
Geriatric Patients: The effect of age on cefdinir pharmacokinetics after a single mg dose was evaluated in 32 subjects 19 to 91 years of age. This increase was due to a reduction in cefdinir clearance. Mechanism of Action:. As with other cephalosporins, bactericidal activity of cefdinir results from inhibition of cell wall synthesis.
As a result, many organisms resistant to penicillins and some cephalosporins are susceptible to cefdinir. Cefdinir is inactive against most strains of Enterobacter spp. Gram-Positive Bacteria:.
Gram-Negative Bacteria:. The following in vitro data are available, but their clinical significance is unknown. Susceptibility Test Methods:. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. Only intramuscular penicillin has been demonstrated to be effective for the prevention of rheumatic fever. Cefdinir is contraindicated in patients with known allergy to the cephalosporin class of antibiotics. Clostridium difficile associated diarrhea CDAD has been reported with use of nearly all antibacterial agents, including Cefdinir, and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. Hypertoxin producing strains of C. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. Prescribing cefdinir capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms.
Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate alternative therapy should be administered. Cefdinir, as with other broad-spectrum antimicrobials antibiotics , should be prescribed with caution in individuals with a history of colitis.
Patients should be counseled that antibacterial drugs including cefdinir capsules should only be used to treat bacterial infections. They do not treat viral infections e. When cefdinir capsules is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
Skipping doses or not completing the full course of therapy may 1 decrease the effectiveness of the immediate treatment and 2 increase the likelihood that bacteria will develop resistance and will not be treatable by cefdinir capsules or other antibacterial drugs in the future. Antacids containing magnesium or aluminum interfere with the absorption of cefdinir. If this type of antacid is required during cefdinir therapy, cefdinir should be taken at least 2 hours before or after the antacid.
Iron supplements, including multivitamins that contain iron, interfere with the absorption of cefdinir. If iron supplements are required during cefdinir therapy, cefdinir should be taken at least 2 hours before or after the supplement.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools with or without stomach cramps and fever even as late as two or more months after having taken the last dose of the antibiotic.
If this occurs, patients should contact their physician as soon as possible. Time to reach C max is also prolonged by 1 hour. There are no significant effects on cefdinir pharmacokinetics if the antacid is administered 2 hours before or 2 hours after cefdinir.
If antacids are required during cefdinir capsules therapy, cefdinir capsules should be taken at least 2 hours before or after the antacid. The effect of foods highly fortified with elemental iron primarily iron-fortified breakfast cereals on cefdinir absorption has not been studied. There have been reports of reddish stools in patients receiving cefdinir. In many cases, patients were also receiving iron-containing products. The reddish color is due to the formation of a nonabsorbable complex between cefdinir or its breakdown products and iron in the gastrointestinal tract.
A false-positive reaction for ketones in the urine may occur with tests using nitroprusside, but not with those using nitroferricyanide. Cephalosporins are known to occasionally induce a positive direct Coombs' test.
The carcinogenic potential of cefdinir has not been evaluated. No mutagenic effects were seen in the bacterial reverse mutation assay Ames or point mutation assay at the hypoxanthine-guanine phosphoribosyltransferase locus HGPRT in V79 Chinese hamster lung cells. No clastogenic effects were observed in vitro in the structural chromosome aberration assay in V79 Chinese hamster lung cells or in vivo in the micronucleus assay in mouse bone marrow.
No effects were observed on maternal reproductive parameters or offspring survival, development, behavior, or reproductive function. There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefdinir has not been studied for use during labor and delivery. Following administration of single mg doses, cefdinir was not detected in human breast milk. Safety and efficacy in neonates and infants less than 6 months of age have not been established. Use of cefdinir for the treatment of acute maxillary sinusitis in pediatric patients age 6 months through 12 years is supported by evidence from adequate and well-controlled studies in adults and adolescents, the similar pathophysiology of acute sinusitis in adult and pediatric patients, and comparative pharmacokinetic data in the pediatric population.
Efficacy is comparable in geriatric patients and younger adults. While cefdinir has been well-tolerated in all age groups, in clinical trials geriatric patients experienced a lower rate of adverse events, including diarrhea, than younger adults. Most adverse events were mild and self-limiting. No deaths or permanent disabilities were attributed to cefdinir. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or nausea. Nineteen of 0.
The following laboratory value changes of possible clinical significance, irrespective of relationship to therapy with cefdinir, were seen during clinical trials conducted in the US:. The following adverse events and altered laboratory tests have been reported for cephalosporin-class antibiotics in general:. Allergic reactions, anaphylaxis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, false-positive test for urinary glucose, neutropenia, pancytopenia, and agranulocytosis.
If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated. Information on cefdinir overdosage in humans is not available. Hemodialysis removes cefdinir from the body.
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No clastogenic effects were observed in vitro in the structural chromosome aberration assay in V79 Chinese hamster lung cells or in vivo in the micronucleus assay in mouse bone marrow. No effects were observed on maternal reproductive parameters or offspring survival, development, behavior, or reproductive function.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Cefdinir has not been studied for use during labor and delivery. Following administration of single mg doses, cefdinir was not detected in human breast milk. Safety and efficacy in neonates and infants less than 6 months of age have not been established.
Use of cefdinir for the treatment of acute maxillary sinusitis in pediatric patients age 6 months through 12 years is supported by evidence from adequate and well-controlled studies in adults and adolescents, the similar pathophysiology of acute sinusitis in adult and pediatric patients, and comparative pharmacokinetic data in the pediatric population.
Efficacy is comparable in geriatric patients and younger adults. While cefdinir has been well-tolerated in all age groups, in clinical trials geriatric patients experienced a lower rate of adverse events, including diarrhea, than younger adults. Most adverse events were mild and self-limiting. No deaths or permanent disabilities were attributed to cefdinir. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or nausea.
Nineteen of 0. The following laboratory value changes of possible clinical significance, irrespective of relationship to therapy with cefdinir, were seen during clinical trials conducted in the US:.
The following adverse events and altered laboratory tests have been reported for cephalosporin-class antibiotics in general:. Allergic reactions, anaphylaxis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, false-positive test for urinary glucose, neutropenia, pancytopenia, and agranulocytosis.
If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated. Information on cefdinir overdosage in humans is not available. Hemodialysis removes cefdinir from the body. This may be useful in the event of a serious toxic reaction from overdosage, particularly if renal function is compromised.
The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, cefdinir capsules should be administered twice daily in these infections.
Cefdinir capsules may be taken without regard to meals. Creatinine clearance is difficult to measure in outpatients.
However, the following formula may be used to estimate creatinine clearance CL cr in adult patients. For estimates to be valid, serum creatinine levels should reflect steady-state levels of renal function. Using strict evaluability and clinical response criteria 6 to 14 days posttherapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes were obtained:. In four controlled studies conducted in the United States, cefdinir was compared with 10 days of penicillin in adult, adolescent, and pediatric patients.
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NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. Pharmacokinetics and Drug Metabolism: Absorption: Oral Bioavailability: Maximal plasma cefdinir concentrations occur 2 to 4 hours postdose following capsule or suspension administration. Distribution: The mean volume of distribution Vd area of cefdinir in adult subjects is 0. Metabolism and Excretion: Cefdinir is not appreciably metabolized.
Special Populations: Patients with Renal Insufficiency: Cefdinir pharmacokinetics were investigated in 21 adult subjects with varying degrees of renal function. Microbiology: Mechanism of Action: As with other cephalosporins, bactericidal activity of cefdinir results from inhibition of cell wall synthesis.
Gram-Positive Bacteria: Staphylococcus aureus methicillin-susceptible strains only Streptococcus pneumoniae penicillin-susceptible strains only Streptococcus pyogenes Gram-Negative Bacteria: Haemophilus influenzae Haemophilus parainfluenzae Moraxella catarrhalis The following in vitro data are available, but their clinical significance is unknown.
General: Prescribing cefdinir capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. Information for Patients: Patients should be counseled that antibacterial drugs including cefdinir capsules should only be used to treat bacterial infections. Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of cefdinir has not been evaluated.
Labor and Delivery: Cefdinir has not been studied for use during labor and delivery. Nursing Mothers: Following administration of single mg doses, cefdinir was not detected in human breast milk. Pediatric Use: Safety and efficacy in neonates and infants less than 6 months of age have not been established.
Geriatric Use: Efficacy is comparable in geriatric patients and younger adults. Cephalosporin Class Adverse Events: The following adverse events and altered laboratory tests have been reported for cephalosporin-class antibiotics in general: Allergic reactions, anaphylaxis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, false-positive test for urinary glucose, neutropenia, pancytopenia, and agranulocytosis.
Patients on Hemodialysis: Hemodialysis removes cefdinir from the body. Prediction of creatinine clearance from serum creatinine.
Nephron ; A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics ; A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatrics ; Manufactured for: Lupin Pharmaceuticals, Inc.
Revised: June ID Version Files May 13, 5 current download Dec 4, 4 download Feb 24, 3 download Apr 18, 1 download. NDC 1 AUC mcg. Type of Infection. Uncomplicated Skin and Skin Structure Infections. Cefdinir BID. Cefaclor TID. Clinical Cure Rates Eradication Rates. Efficacy Parameter.
Cefdinir QD. Penicillin QID. Eradication of S. Product Information. Inactive Ingredients. Product Characteristics. Marketing Information. Labeler - Lupin Pharmaceuticals, Inc. Use in pregnancy: The safety of cefdinir in pregnant women has not been established. Therefore, cefdinir should only be used in pregnant women and women suspected of being pregnant, provided that the expected therapeutic benefits are evaluated to outweigh the possible risk of treatment. Adverse Reactions. Shock: It may occur rarely.
Patients should be carefully observed, and therapy discontinued, in the event of symptoms eg, discomfort, paresthesias of the mouth, wheezing, vertigo, desire to defecate, tinnitus or diaphoresis, etc.
Hypersensitivity: If signs of hypersensitivity reactions eg, rash, urticaria, erythema, pruritus or fever occur, Omnicef should be discontinued and appropriate measures should be taken. Hematologic: Granulocytopenia or eosinophilia may occur infrequently. Omnicef should be discontinued if any of these abnormalities is found. It has been reported that hemolytic anemia has occurred with other cephem antibiotics. Renal: Infrequently, an increase in BUN may occur. It has been reported that serious renal impairment eg, acute renal insufficiency, may rarely occur with other cephem antibiotics.
If any of these abnormalities is found, discontinuation of Omnicef and appropriate measures should be taken. Gastrointestinal: It has been reported that serious colitis eg, pseudomembranous colitis, manifested by blood in stools, may occur with other cephem antibiotics.
Infrequently nausea, diarrhea, abdominal pain, stomach discomfort, heartburn or anorexia, and rarely constipation may occur. Respiratory: It has been reported that interstitial pneumonia or PTE syndrome, manifested by fever, cough dyspnea, abnormal x-ray or eosinophilia, may rarely occur with other cephem antibiotics.
If any such symptoms occur, Omnicef should be discontinued and appropriate measures eg, giving adrenocortical hormones should be taken.
Substituted Microbism: Rarely, stomatitis or candidiasis may occur. Avitaminosis: Rarely, vitamin K deficiencies eg, hypoprothrombinemia or bleeding tendencies or vitamin B-group deficiencies eg, glossitis, stomatitis, anorexia or neuritis may occur.
Others: Rarely, headache, dizziness or chest pressure sensation may occur. Drug Interactions. Action of cefdinir may diminish as a result of reduced oral availability by the concomitant use with iron preparations and antacids. Influences on Laboratory Values: False-positive results may occur in urine sugar tests with Benedict's solution, Fehling's solution and Clinitest. False-positives have not been reported with Tes-Tape. A positive direct Coombs' test may occur. MIMS Class. ATC Classification.
J01DD15 - cefdinir ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Manufacturer: Pfizer. Distributor: DKSH. Full Prescribing Info. Cefdinir is an oral cephem antibiotic which has a vinyl group at the 3-position and a 2-aminothiazolyl hydroxyimino group at the 7-position of 7-aminocephalosporanic acid. Pharmacology: Antibacterial Activity: Cefdinir has broad-spectrum activity against gram-positive and gram-negative microorganisms. In particular, in comparison with the other oral cephems, it has potent activity against such gram-positive microorganisms as Staphylococcus and Streptococcus spp.
Its mechanism of action is bactericidal. Mechanism of Action: Its mechanism of action is inhibition of cell wall synthesis. It has high affinity for penicillin-binding proteins PBP 1 1a, 1b2 and 3, with the site of activity varying according to organism. Treatment of the following infections caused by Omnicef-susceptible strains of Staphylococcus sp, Streptococcus sp, Streptococcus pneumoniaePeptostreptococcus and Propionibacterium spp, Neisseria gonorrhoeaeBranhamella catarrhalisEscherichia coliKlebsiella sp, Proteus mirabilisProvidencia sp and Haemophilus influenzae : Folliculitis, furuncle, furunculosis, carbuncle, impetigo contagiosa, erysipelas, phlegmon, lymphangitis lymphadenitisfelon, suppurative paronychia, subcutaneous abscess, hidradenitis, infectious atheroma, chronic pyoderma.
Pyelonephritis, cystitis. Uterine adnexitis, intrauterine infection, bartholinitis. Adults: mg potency of cefdinir every 8 hrs orally. Children: The recommended dosage and duration of treatment for children are described for various infections or by body weight in the following table.
See table. Maximum daily dose of cefdinir is mg. Patients with a history of shock due to any ingredient of Omnicef. Patients with a history of hypersensitivity to any ingredients of Omnicef or other cephem antibiotics.
Special Precautions. General: Careful inquiry about any form of hypersensitivity should be made, since reactions eg, shock may occur.
Careful administration is required in patients with: History of hypersensitivity to penicillins; personal or familial predisposition to allergic reactions eg, bronchial asthma, rash or urticaria; serious renal function disorder; poor oral nutrition, receiving parenteral nutrition, elderly or patients in a debilitated state.
Careful observation is essential in these patients as vitamin K deficiency symptoms may develop. Use in pregnancy: The safety of cefdinir in pregnant women has not been established.
Therefore, cefdinir should only be used in pregnant women and women suspected of being pregnant, provided that the expected therapeutic benefits are evaluated to outweigh the possible risk of treatment. Adverse Reactions. Shock: It may occur rarely. Patients should be carefully observed, and therapy discontinued, in the event of symptoms eg, discomfort, paresthesias of the mouth, wheezing, vertigo, desire to defecate, tinnitus or diaphoresis, etc.
Hypersensitivity: If signs of hypersensitivity reactions eg, rash, urticaria, erythema, pruritus or fever occur, Omnicef should be discontinued and appropriate measures should be taken. Hematologic: Granulocytopenia or eosinophilia may occur infrequently.
Omnicef should be discontinued if any of these abnormalities is found. It has been reported that hemolytic anemia has occurred with other cephem antibiotics. Renal: Infrequently, an increase in BUN may occur.
It has been reported that serious renal impairment eg, acute renal insufficiency, may rarely occur with other cephem antibiotics. If any of these abnormalities is found, discontinuation of Omnicef and appropriate measures should be taken. Gastrointestinal: It has been reported that serious colitis eg, pseudomembranous colitis, manifested by blood in stools, may occur with other cephem antibiotics.
Infrequently nausea, diarrhea, abdominal pain, stomach discomfort, heartburn or anorexia, and rarely constipation may occur. Respiratory: It has been reported that interstitial pneumonia or PTE syndrome, manifested by fever, cough dyspnea, abnormal x-ray or eosinophilia, may rarely occur with other cephem antibiotics.
If any such symptoms occur, Omnicef should be discontinued and appropriate measures eg, giving adrenocortical hormones should be taken. Substituted Microbism: Rarely, stomatitis or candidiasis may occur. Avitaminosis: Rarely, vitamin K deficiencies eg, hypoprothrombinemia or bleeding tendencies or vitamin B-group deficiencies eg, glossitis, stomatitis, anorexia or neuritis may occur. Others: Rarely, headache, dizziness or chest pressure sensation may occur.
Drug Interactions. Action of cefdinir may diminish as a result of reduced oral availability by the concomitant use with iron preparations and antacids. Influences on Laboratory Values: False-positive results may occur in urine sugar tests with Benedict's solution, Fehling's solution and Clinitest.
False-positives have not been reported with Tes-Tape. A positive direct Coombs' test may occur. MIMS Class. ATC Classification. J01DD15 - cefdinir ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections. Thai FDA Category. Register or sign in to continue.
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FDA, U.S. Food and Drug Administration Omnicef (Cefdinir) Capsules & Oral Suspension Company: Parke-Davis Application No. Cefdinir for oral suspension USP is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of. Cefdinir, sold under the brand name Omnicef among others, is an antibiotic used to treat pneumonia, otitis media, strep throat, and cellulitis. Cefdinir is FDA approved for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated bacteria in the. Find patient medical information for Omnicef oral on WebMD including its uses, report side effects to FDA at FDA or at localhost Sign in. As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Patients with a history of shock due to any ingredient of Omnicef. Cefdinir has not, however, been studied for the prevention of rheumatic fever following S. There are, however, no adequate and well-controlled studies in pregnant women. Mechanism of Action: Its mechanism of action is inhibition of cell wall synthesis. Manufacturer: Pfizer.Clean the skin with a mild soap-free steel or wash the skin with puffed water and dry the skin needs. For people with permission skin, it is recommended to widen the gel once a day before taking to sleep.
Wash off the gel there in the morning. We phase that you only use this product if you are well informed.
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