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ABSORICA LD is a brand name for Isotretinoin, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Absorica LD® (isotretinoin capsules) is indicated for the treatment of: • Severe Nodular and/or Inflammatory Acne • Acne Conglobata • Recalcitrant Acne Because of significant adverse reactions associated with its use, Absorica LD should be reserved for patients where the conditions listed above are unresponsive to…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Reserve for patients who are unresponsive to conventional first line therapies for the indicated conditions. • Carefully assess the patient’s mental state, including whether or not they have a history of previous psychiatric illness (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX and Psychiatric).
• Limit each prescription to 30-day treatment • Dispense within a maximum of 7 days of the prescription • The therapeutic response to isotretinoin is dose-related and varies between patients. This necessitates individual adjustment of dosage according to the response of the condition and the patient’s tolerance of the drug.
In most cases, complete or near-complete suppression of acne is achieved with a single 15 to 20 week course of therapy. If a second course of therapy is needed, it can be initiated two months or more after completion of the first course, since experience has shown that patients may continue to improve while off the drug.
Absorica LD capsules are not interchangeable with any other currently available isotretinoin-containing products. 4. Administration, Laboratory Testing Prior to Administration. 2 Recommended Dose and Dosage Adjustment The initial dose of Absorica LD should be individualized according to the patient’s weight and severity of the disease.
8 mg/kg body weight daily taken with or without meals (see Table 1). 6 mg/kg/day depending upon individual patient response and tolerance to the drug. Absorica LD should be taken in the nearest number of whole capsules, either as a single dose or in two divided doses during the day, whichever is more convenient.
To decrease the risk of esophageal irritation, instruct patients to swallow the capsules with a full glass of liquid. Do not chew or open the capsules. It should be noted that transient exacerbation of acne is occasionally seen. Health Canada has not authorized an indication for pediatric use younger than 12 years of age.
6 mg/kg 40 16 32 64 50 20 40 80 60 24 48 96 70 28 56 112 80 32 64 128 90 36 72 144 100 40 80 160 1 Administer in the nearest number of whole capsules, either as a single dose or in two divided doses.
Duration of Use:
A normal, complete course of treatment is 15 to 20 weeks. If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, treatment with Absorica LD may be discontinued. After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of Absorica LD may be initiated in patients who have completed skeletal growth.
, Abnormal Laboratory Findings). Patients with increased tendency to develop hypertriglyceridemia include those with diabetes mellitus, obesity, increased alcohol intake, lipid metabolism disorder and familial history. In these high-risk patients, more frequent checks of serum values for lipids (see Endocrine and Metabolism and Hepatic/Biliary/Pancreatic) and/or blood glucose may be necessary while undergoing treatment with Absorica LD.
Absorica LD® (isotretinoin) Product Monograph Page 13 of 51 The cardiovascular consequences of hypertriglyceridemia are not well understood, but may increase the patient’s risk status. Therefore, every attempt should be made to control significant triglyceride elevation (see Monitoring and Laboratory Tests).
Some patients have been able to reverse triglyceride elevation by reduction in weight, restriction of dietary fat and alcohol, and reduction in dose while continuing isotretinoin. An obese male patient with Darier’s disease developed elevated triglycerides and subsequent eruptive xanthomas.
Ear / Nose / Throat Impaired hearing, at certain frequencies, has been reported in some patients treated with isotretinoin. Patients who experience tinnitus or hearing impairment should discontinue Absorica LD treatment and be referred for specialized care for further evaluation.
In some cases, the hearing impairment has been reported to persist after therapy has been discontinued. Mechanism(s) and causality for this reaction have not been established. Endocrine and Metabolism Patients with diabetes or a family history of diabetes may experience problems with the control of their blood sugar during Absorica LD therapy.
Therefore, known or suspected diabetics should have periodic blood sugar determinations. 2 ADVERSE REACTIONS, Abnormal Laboratory Findings). Gastrointestinal Isotretinoin has been associated with inflammatory bowel disease (including regional ileitis, colitis and hemorrhage) in patients without a prior history of intestinal disorders.
, Musculoskeletal 11/2024 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential, Function 11/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics.........................................................................................................
2 Geriatrics ......................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations......................................................................................
2 Recommended Dose and Dosage Adjustment ................................................... 4 Administration ................................................................................................. 5 Missed Dose ....................................................................................................
9 5 OVERDOSAGE ............................................................................................................. 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 10 7 WARNINGS AND PRECAUTIONS ................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The use of another course of Absorica LD therapy is not recommended before a two-month waiting period because the patient’s acne may continue to improve after a 15 to 20-week course of therapy. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth.
Long-term use of Absorica LD, even in low dosages, has not been studied, and is not recommended. The effect of long-term use of Absorica LD on bone loss is unknown (see Musculoskeletal). 4 Administration Absorica LD is for oral use only.
5 Missed Dose If a patient misses a dose of Absorica LD, it may be taken later the same day, but, the patient should be instructed to not take more Absorica LD in one day than what has been prescribed. The patient should then administer the next dose on the usual scheduled dosing day.
The patient should not take a double dose to make up for a missed dose.
Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Absorica LD immediately. In some instances symptoms have been reported to persist after isotretinoin treatment has been stopped. Hepatic / Biliary / Pancreatic Absorica LD is contraindicated in patients with hepatic insufficiency (See 2 CONTRAINDICATIONS).
Liver function tests should be monitored before treatment and at regular intervals during treatment (one month after the start of treatment and at least three month intervals thereafter) unless more frequent monitoring is clinically indicated.
Several case s of clinical hepatitis have been noted which are considered to be possibly or probably related to isotretinoin therapy. Additionally, mild to moderate elevations of liver enzymes have been observed in approximately 15% of individuals treated during clinical trials, some of which normalized with dosage reduction or continued administration of the drug.
If normalization does not readily occur, or if hepatitis is suspected during treatment with Absorica LD, the drug should be discontinued and the etiology further investigated (see Monitoring and Laboratory Tests). Acute pancreatitis, which is known to be potentially fatal, has been reported with isotretinoin use in patients with either elevated or normal serum triglyceride levels.
This is sometimes associated with elevation of serum triglycerides in excess of 800 mg/dL or 9 mmol/L. Absorica LD® (isotretinoin) Product Monograph Page 14 of 51 Therefore, every attempt should be made to control significant triglyceride elevation (see Cardiovascular).
Absorica LD should be discontinued if uncontrolled hypertriglyceridemia or symptoms of pancreatitis occur. Immune Anaphylactic reactions and other allergic reactions have been reported with isotretinoin use. These reactions were more serious after prior exposure to topical retinoids.
Allergic cutaneous reactions and serious cases of allergic vasculitis, often with purpura (bruises and red patches) of the extremities and extracutaneous involvement have been reported. Severe allergic reactions necessitate discontinuation of therapy and careful monitoring.
Monitoring and Laboratory Tests Pregnancy Tests The patient should have two negative pregnancy tests (β-hCG in urine or serum) before starting Absorica LD therapy with the first pregnancy test conducted at initial assessment when the patient is qualified for Absorica LD therapy by the physician.
The patient then should have a second pregnancy test with a sensitivity of at least 25 mIU/mL with a negative result, performed in a licensed laboratory, within 11 days prior to initiating therapy. The patient has had two or three days of the next normal menstrual period before Absorica LD therapy is initiated.
Pregnancy test must be repeated monthly for pregnancy detection during Absorica LD treatment and at one month after discontinuation of treatment. The dates and results of the pregnancy tests should be documented. Signs of Depression Prior to initiation of Absorica LD therapy, patients and family members should be asked about any history of psychiatric disorder, and at each visit during therapy patients should be assessed for symptoms of depression, mood disturbance, psychosis, or aggression to determine if further evaluation is necessary (See Psychiatric).
Patients should immediately stop Absorica LD and the patient (or caregiver) should promptly contact their prescriber if the patient develops depression, mood disturbance, psychosis, or aggression. Discontinuation of Absorica LD may be insufficient; further evaluation may be necessary such as a referral to a mental health professional.
The following tests are required before starting Absorica LD at first month, then as clinically indicated: • Serum blood […]
1 Special Populations ........................................................................................ 1 Pregnant Women ....................................................................................... 2 Breast-feeding............................................................................................
3 Pediatrics ................................................................................................... 4 Geriatrics ................................................................................................... 22 8 ADVERSE REACTIONS ................................................................................................
1 Adverse Reaction Overview ............................................................................ 2 Clinical Trial Adverse Reactions ...................................................................... 1 Clinical Trial Adverse Reactions – Pediatrics ................................................
3 Less Common Clinical Trial Adverse Reactions ................................................ 1 Less Common Clinical Trial Adverse Reactions – Pediatrics .......................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ......................................................................................................
5 Post-Market Adverse Reactions ...................................................................... 27 9 DRUG INTERACTIONS................................................................................................ 1 Serious Drug Interactions ...............................................................................
2 Drug Interactions Overview ............................................................................ 4 Drug-Drug Interactions................................................................................... 5 Drug-Food Interactions ..................................................................................
6 Drug-Herb Interactions................................................................................... 7 Drug-Laboratory Test Interactions .................................................................. 30 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action ..................................................................................... 2 Pharmacodynamics ........................................................................................ 3 Pharmacokinetics...........................................................................................
30 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 31 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 32 PART II: SCIENTIFIC INFORMATION ......................................................................................
33 13 PHARMACEUTICAL INFORMATION............................................................................ 33 14 CLINICAL TRIALS........................................................................................................
1 Clinical Trials by Indication ............................................................................. 33 Severe Recalcitrant Nodular Acne .............................................................................. 2 Comparative Bioavailability Studies ................................................................
35 15 MICROBIOLOGY ........................................................................................................ 36 16 NON-CLINICAL TOXICOLOGY […]