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APO-DOXYCYCLINE MODIFIED RELEASE is a brand name for Doxycycline, supplied as a capsule (immediate and extended release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................................... 3 CONTRAINDICATIONS ..................................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations The dosage of APO-DOXYCYCLINE MODIFIED RELEASE capsules differs from that of doxycycline used to treat infections. Exceeding the recommended dosage may result in an increased incidence of side effects including the development of resistant organisms.
Efficacy and safety of doxycycline modified-release capsules for the treatment of rosacea beyond 16 weeks have not been established. Recommended Dose and Dosage Adjustment One APO-DOXYCYCLINE MODIFIED RELEASE capsule (40 mg, modified-release) should be taken once daily in the morning, on an empty stomach, preferably at least one hour prior to or two hours after the meal.
Administration Administration of adequate amounts of fluid along with the capsule is recommended to wash down the APO- DOXYCYCLINE MODIFIED RELEASE capsule to reduce the risk of esophageal irritation and ulceration (see WARNINGS AND PRECAUTIONS – Gastrointestinal).
Special Populations:
Pediatrics (<18 years of age): APO-DOXYCYCLINE MODIFIED RELEASE has not been evaluated in pediatric subjects. The use of doxycycline is contraindicated in children up to the age of 8 years due to the risk of dental discolouration and decreased bone growth.
See section Special Warnings and Precautions for Use.
Gastric Insufficiency:
APO-DOXYCYCLINE MODIFIED RELEASE is not recommended in patients with gastrectomy, gastric bypass surgery or any surgeries that bypass or exclude the duodenum, or who are otherwise deemed achlorhydric (see ACTION AND CLINICAL PHARMACOLOGY - Pharmacokinetics).
Missed Dose If a single dose of APO-DOXYCYCLINE MODIFIED RELEASE is missed, that daily dose should be skipped and the patient should be instructed to take the next dose at the regular time. OVERDOSAGE For management of a suspected drug overdose, contact your regional Poison Control Centre.
No cases of overdose have been reported during clinical trials with doxycycline modified-release capsules. In the case of overdosage, the medication should be discontinued immediately and the patient should be treated symptomatically.
Dialysis does not alter doxycycline pharmacokinetics and therefore would not be of benefit in treating cases of overdose. ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action The pathophysiology of the inflammatory lesions of rosacea is, in part, a manifestation of a neutrophil- mediated process.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Doxycycline in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Doxycycline has been shown to inhibit neutrophil activity and several pro-inflammatory reactions including those associated with phospholipase A2, endogenous nitric oxide and interleukin-6. The clinical significance of these findings is not known.
Page 12 of 26 Pharmacokinetics Doxycycline modified-release capsules are not bioequivalent to other doxycycline products. The pharmacokinetics of doxycycline following oral administration of doxycycline modified-release capsules was investigated in two studies involving 61 adults.
Pharmacokinetic parameters for doxycycline modified-release capsules following single oral doses and at steady-state (7 consecutive days) in fasting healthy subjects are presented in Table 2 below. 2 *Mean ±SD, **Median (range), ***Day 7 The plasma concentration of doxycycline following administration of doxycycline modified-release capsules was well below the level required to inhibit microorganisms commonly associated with bacterial disease.
Absorption:
Doxycycline is almost completely absorbed after oral administration. In a single-dose food- effect study involving administration of doxycycline modified-release capsules to healthy volunteers, co-administration with a 1000 calorie, high-fat, high protein meal that included dairy products reduced the bioavailability (AUC) of doxycycline from doxycycline modified-release capsules by about 20% and reduced the peak plasma level by 43%, compared to dosing under fasted conditions.
Distribution:
No new distribution studies have been performed with doxycycline modified-release capsules since doxycycline is a well-established drug substance. Doxycycline is lipophilic and widely distributed in the tissues. 6 to 134 L. Information from the literature indicates that doxycycline is about 80-90% bound to plasma proteins.
Metabolism:
No new metabolism studies have been performed with doxycycline modified-release capsules since doxycycline is a well- established drug substance. Major metabolites of doxycycline have not been identified. However, enzyme inducers such as barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline (for a comprehensive list of enzyme inducers, see DRUG INTERACTIONS - Drug-Drug Interactions).
Excretion:
Doxycycline is excreted in the urine and faeces as almost unmetabolized drug. Between 29-55% of an administered dose can be accounted for in the urine within 72 hours.
Special Populations and Conditions Pediatrics (<18 years of age):
Pharmacokinetic studies have not been conducted in children 18 years old or younger.
Geriatrics (≥ 65 years of age):
Doxycycline pharmacokinetics have not been evaluated in geriatric patients.
Gender:
The pharmacokinetics of doxycycline modified-release capsules were compared in 16 male and 14 female subjects Page 13 of 26 under fed and fasted conditions. Female subjects had a higher Cmax and AUC than male subjects, however a subgroup analysis by gender of the Phase 3 clinical studies did not show a gender difference in clinical outcome.
Renal Insufficiency:
Studies have shown no significant difference in serum half-life of doxycycline in patients with normal and severely impaired renal function. Hemodialysis does not alter the serum half-life of doxycycline. […]