Active ingredient: Doxycycline Monohydrate

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Doxycycline Monohydrate uses


1 INDICATIONS AND USAGE

- Doxycycline Monohydrate is a tetracycline-class drug indicated for the treatment of only inflammatory lesions of rosacea in adult patients. (1.1)

Limitations of Use

- This formulation of Doxycycline Monohydrate has not been evaluated in the treatment or prevention of infections. (1.2)

- Efficacy of Doxycycline Monohydrate beyond 16 weeks and safety beyond 9 months have not been established. (1.2)

1.1 Indication

Doxycycline Monohydrate is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea.

1.2 Limitations of Use

This formulation of Doxycycline Monohydrate has not been evaluated in the treatment or prevention of infections. Doxycycline Monohydrate should not be used for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease.

To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Doxycycline Monohydrate should be used only as indicated.

Efficacy of Doxycycline Monohydrate beyond 16 weeks and safety beyond 9 months have not been established.

Doxycycline Monohydrate has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea.

2 DOSAGE AND ADMINISTRATION

- One Doxycycline Monohydrate Capsule should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals. (2.1)

- The dosage of Doxycycline Monohydrate differs from that of Doxycycline Monohydrate used to treat infections. Exceeding the recommended dosage may result in an increased incidence of side effects including the development of resistant microorganisms. (2.2, 5.5)

2.1 General Dosing Information

One Doxycycline Monohydrate Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals.

Administration of adequate amounts of fluid along with the capsules is recommended to wash down the capsule to reduce the risk of esophageal irritation and ulceration.

2.2 Important Considerations for Dosing Regimen

The dosage of Doxycycline Monohydrate differs from that of Doxycycline Monohydrate used to treat infections. Exceeding the recommended dosage may result in an increased incidence of side effects including the development of resistant organisms.

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3 DOSAGE FORMS AND STRENGTHS

40 mg beige opaque capsule imprinted with “GLD 40”

- 40 mg capsule. (3)

4 CONTRAINDICATIONS

​This drug is contraindicated in persons who have shown hypersensitivity to Doxycycline Monohydrate or any of the other tetracyclines.

- Doxycycline Monohydrate is contraindicated in persons who have shown hypersensitivity to Doxycycline Monohydrate or other tetracyclines. (4)

5 WARNINGS AND PRECAUTIONS

- The use of Doxycycline Monohydrate during tooth development may cause permanent discoloration of the teeth (yellow-gray-brown). (5.1)

- If pseudomembranous colitis occurs, discontinue Doxycycline Monohydrate. (5.2)

- If renal impairment exists, Doxycycline Monohydrate doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver injury. (5.3)

- Photosensitivity can occur with Doxycycline Monohydrate; Patients should minimize or avoid exposure to natural or artificial sunlight. (5.4)

- Tetracyclines have been associated with the development of autoimmune syndromes; if symptoms develop, discontinue Doxycycline Monohydrate immediately. (5.5)

- Doxycycline Monohydrate may cause pseudotumor cerebri (benign intracranial hypertension). Discontinue Doxycycline Monohydrate if symptoms occur. (5.7)

- Bacterial resistance to tetracyclines may develop in patients using Doxycycline Monohydrate. It should only be used as indicated. (5.8)

5.1 Teratogenic Effects

Doxycycline Monohydrate should not be used during pregnancy.

Doxycycline Monohydrate, like other tetracycline-class antibiotics, can cause fetal harm when administered to a pregnant woman. If any tetracycline is used during pregnancy or if the patient becomes pregnant while taking these drugs, the patient should be informed of the potential hazard to the fetus and treatment stopped immediately.

The use of drugs of the tetracycline-class during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. Tetracycline drugs, therefore, should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated.

All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development on the developing fetus. Evidence of embryotoxicity has been noted in animals treated early in pregnancy.

5.2 Pseudomembranous Colitis

Clostridium difficile associated diarrhea has been reported with nearly all antibacterial agents, including Doxycycline Monohydrate, and may range in severity from mild to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

5.3 Metabolic Effects

The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class antibiotics may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable.

5.4 Photosensitivity

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Although this was not observed during the duration of the clinical studies with Doxycycline Monohydrate, patients should minimize or avoid exposure to natural or artificial sunlight while using Doxycycline Monohydrate. If patients need to be outdoors while using Doxycycline Monohydrate, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician.

5.5 Autoimmune Syndromes

Tetracyclines have been associated with the development of autoimmune syndromes. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In symptomatic patients, liver function tests, ANA, CBC, and other appropriate tests should be performed to evaluate the patients. Use of all tetracycline-class drugs should be discontinued immediately.

5.6 Tissue Hyperpigmentation

Tetracycline-class drugs are known to cause hyperpigmentation. Tetracycline therapy may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity, sclerae and heart valves. Skin and oral pigmentation has been reported to occur independently of time or amount of drug administration, whereas other pigmentation has been reported to occur upon prolonged administration. Skin pigmentation includes diffuse pigmentation as well as over sites of scars or injury.

5.7 Pseudotumor Cerebri

Pseudotumor cerebri (benign intracranial hypertension) in adults has been associated with the use of tetracyclines. The usual clinical manifestations are headache and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. While both of these conditions and related symptoms usually resolve after discontinuation of the tetracycline, the possibility for permanent sequelae exists. Patients should be questioned for visual disturbances prior to initiation of treatment with tetracyclines and should be routinely checked for papiledema while on treatment.

5.8 Development of Drug Resistant Bacteria

Bacterial resistance to tetracyclines may develop in patients using Doxycycline Monohydrate. Because of the potential for drug-resistant bacteria to develop during the use of Doxycycline Monohydrate, it should only be used as indicated.

5.9 Superinfection

As with other antibiotic preparations, use of Doxycycline Monohydrate may result in overgrowth of non-susceptible microorganisms, including fungi. If superinfection occurs, Doxycycline Monohydrate should be discontinued and appropriate therapy instituted. Although not observed in clinical trials with Doxycycline Monohydrate, the use of tetracyclines may increase the incidence of vaginal candidiasis. Doxycycline Monohydrate should be used with caution in patients with a history of or predisposition to Candida overgrowth.

5.10 Laboratory Monitoring

Periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies should be performed. Appropriate tests for autoimmune syndromes should be performed as indicated.

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6 ADVERSE REACTIONS

Some of the most common adverse reactions are nasopharyngitis, sinusitis, diarrhea, hypertension and aspartate aminotransferase increase. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse Reactions in Clinical Trials of Doxycycline Monohydrate: In controlled clinical trials of adult subjects with mild to moderate rosacea, 537 subjects received Doxycycline Monohydrate or placebo over a 16-week period. The following table summarizes selected adverse reactions that occurred in the clinical trials at a rate of ≥1% for the active arm:

Note: Percentages based on total number of study participants in each treatment group.

Adverse Reactions for Tetracyclines: The following adverse reactions have been observed in patients receiving tetracyclines at higher, antimicrobial doses:

Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital region. Hepatotoxicity has been reported rarely. Rare instances of esophagitis and esophageal ulcerations have been reported in patients receiving the capsule forms of the drugs in the tetracycline-class. Most of the patients experiencing esophagitis and/or esophageal ulceration took their medication immediately before lying down [see Dosage and Administration (2)].

Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Photosensitivity is discussed above [see Warnings and Precautions (5.4)].

Renal toxicity: Rise in BUN has been reported and is apparently dose related [see Warnings and Precautions (5.3)].

Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic lupus erythematosus.

Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

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6.2 Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their

frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post approval use of Doxycycline Monohydrate:

- Nervous system: Pseudotumor cerebri (benign intracranial hypertension), headache.

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7 DRUG INTERACTIONS

- Patients on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

- Some bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. (7.2)

- The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity. (7.3)

7.1 Anticoagulants

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

7.2 Penicillin

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

7.3 Methoxyflurane

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

7.4 Antacids and Iron Preparations

Absorption of tetracyclines is impaired by bismuth subsalicylate, proton pump inhibitors, antacids containing aluminum, calcium or magnesium and iron-containing preparations.

7.5 Low Dose Oral Contraceptives

Doxycycline Monohydrate may interfere with the effectiveness of low dose oral contraceptives. To avoid contraceptive failure, females are advised to use a second form of contraceptive during treatment with Doxycycline Monohydrate.

7.6 Oral Retinoids

There have been reports of pseudotumor cerebri associated with the concomitant use of isotretinoin and tetracyclines. Since both oral retinoids, including isotretinoin and acitretin, and the tetracyclines, primarily minocycline, can cause increased intracranial pressure, the concurrent use of an oral retinoid and a tetracycline should be avoided.

7.7 Barbiturates and Anti-epileptics

Barbiturates, carbamazepine, and phenytoin decrease the half-life of Doxycycline Monohydrate.

7.8 Drug/Laboratory Test Interactions

False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

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8 USE IN SPECIFIC POPULATIONS

- Doxycycline Monohydrate like other tetracycline-class drugs, can cause fetal harm when administered to a pregnant woman.

- The use of drugs of the tetracycline-class during tooth development may cause permanent discoloration of the teeth. (5.1, 8.4)

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category D [see Warnings and Precautions (5.1)]. Results from animal studies indicate that Doxycycline Monohydrate crosses the placenta and is found in fetal tissues.

8.3 Nursing Mothers

Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in infants from Doxycycline Monohydrate, Doxycycline Monohydrate should not be used in mothers who breastfeed.

8.4 Pediatric Use

Doxycycline Monohydrate should not be used in infants and children less than 8 years of age [see Warnings and Precautions ]. Doxycycline Monohydrate has not been studied in children of any age with regard to safety or efficacy, therefore use in children is not recommended.

8.5 Geriatric Use

Clinical studies of Doxycycline Monohydrate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

10 OVERDOSAGE

In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdose.

11 DESCRIPTION

Doxycycline Monohydrate (doxycycline, USP) Capsules 40 mg are hard gelatin capsule shells filled with two types of Doxycycline Monohydrate beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous Doxycycline Monohydrate (C22H24N2O8).

The structural formula of Doxycycline Monohydrate, USP is:

with an empirical formula of C22H24N2O8-H2O and a molecular weight of 462.46. The chemical designation for Doxycycline Monohydrate is 2-Naphthacenecar-boxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate. It is very slightly soluble in water.

Inert ingredients in the formulation are: hypromellose, iron oxide red, iron oxide yellow, methacrylic acid copolymer, polyethylene glycol, Polysorbate 80, sugar spheres, talc, titanium dioxide, and triethyl citrate. Active ingredients: Each capsule contains Doxycycline Monohydrate, USP in an amount equivalent to 40 mg of anhydrous Doxycycline Monohydrate.

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The mechanism of action of Doxycycline Monohydrate in the treatment of inflammatory lesions of rosacea is unknown.

12.3 Pharmacokinetics

Doxycycline Monohydrate capsules are not bioequivalent to other Doxycycline Monohydrate products. The pharmacokinetics of Doxycycline Monohydrate following oral administration of

Doxycycline Monohydrate was investigated in 2 volunteer studies involving 61 adults. Pharmacokinetic parameters for Doxycycline Monohydrate following single oral doses and at steady-state in healthy subjects are presented in Table 2.

Absorption: In a single-dose food-effect study involving administration of Doxycycline Monohydrate to healthy volunteers, concomitant administration with a 1000 calorie, high-fat, high-protein meal that included dairy products, resulted in a decrease in the rate and extent of absorption by about 45% and 22%, respectively, compared to dosing under fasted conditions. This decrease in systemic exposure can be clinically significant, and therefore if Doxycycline Monohydrate is taken close to meal times, it is recommended that it be taken at least one hour prior to or two hours after meals.

Distribution: Doxycycline Monohydrate is greater than 90% bound to plasma proteins.

Metabolism: Major metabolites of Doxycycline Monohydrate have not been identified. However, enzyme inducers such as barbiturates, carbamazepine, and phenytoin decrease the half-life of Doxycycline Monohydrate.

Excretion: Doxycycline Monohydrate is excreted in the urine and feces as unchanged drug. It is reported that between 29% and 55.4% of an administered dose can be accounted for in the urine by 72 hours. Terminal half-life averaged 21.2 hours in subjects receiving a single dose of Doxycycline Monohydrate.

Special Populations

Geriatric: Doxycycline Monohydrate pharmacokinetics have not been evaluated in geriatric patients.

Pediatric: Doxycycline Monohydrate pharmacokinetics have not been evaluated in pediatric patients.

Gender: The pharmacokinetics of Doxycycline Monohydrate were compared in 16 male and 14 female subjects under fed and fasted conditions. While female subjects had a higher Cmax and AUC than male subjects, these differences were thought to be due to differences in body weight/lean body mass.

Race: Differences in Doxycycline Monohydrate pharmacokinetics among racial groups have not been evaluated.

Renal Insufficiency: Studies have shown no significant difference in serum half-life of Doxycycline Monohydrate in patients with normal and severely impaired renal function. Hemodialysis does not alter the serum half-life of Doxycycline Monohydrate.

Hepatic Insufficiency: Doxycycline Monohydrate pharmacokinetics have not been evaluated in patients with hepatic insufficiency.

Gastric Insufficiency: In a study in healthy volunteers (N=24) the bioavailability of Doxycycline Monohydrate is reported to be reduced at high pH. This reduced bioavailability may be clinically significant in patients with gastrectomy, gastric bypass surgery or who are otherwise deemed achlorhydric.

Drug Interactions:.

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12.4 Microbiology

Doxycycline Monohydrate is a member of the tetracycline-class of drugs. The plasma concentrations of Doxycycline Monohydrate achieved with Doxycycline Monohydrate during administration are less than the concentration required to treat bacterial diseases. Doxycycline Monohydrate should not be used for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease. In vivo microbiological studies utilizing a similar drug exposure for up to 18 months demonstrated no detectable long term effects on bacterial flora of the oral cavity, skin, intestinal tract and vagina.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Doxycycline Monohydrate was assessed for potential to induce carcinogenesis in a study in which the compound was administered to Sprague-Dawley rats by gavage at dosages of 20, 75, and 200 mg/kg/day for two years. An increased incidence of uterine polyps was observed in female rats that received 200 mg/kg/day, a dosage that resulted in a systemic exposure to Doxycycline Monohydrate approximately 12.2 times that observed in female humans who use Doxycycline Monohydrate [exposure comparison based upon area under the curve (AUC) values]. No impact upon tumor incidence was observed in male rats up to at 200 mg/kg/day, or in females at the lower dosages studied.

Doxycyline was assessed for potential to induce carcinogenesis in CD-1 mice by gavage at dosages 20, 75, and 150 mg/kg/day in males and at dosages of 20, 100, and 300 mg/kg/day in females. No impact upon tumor incidence was observed in male and female mice at systemic exposures approximately 4.2 and 8.3 times that observed in humans, respectively.

Doxycycline Monohydrate demonstrated no potential to cause genetic toxicity in an in vitro point mutation study with mammalian cells (CHO/HGPRT forward mutation assay) or in an in vivo micronucleus assay conducted in CD-1 mice. However, data from an in vitro mammalian chromosomal aberration assay conducted with CHO cells suggest that Doxycycline Monohydrate is a weak clastogen. Oral administration of Doxycycline Monohydrate to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance, as evidenced by increased time for mating to occur, reduced sperm motility, velocity, and concentration, abnormal sperm morphology, and increased pre-and post-implantation losses. Doxycycline Monohydrate induced reproductive toxicity at all dosages that were examined in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically significant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 3.6 times the amount of Doxycycline Monohydrate contained in the recommended daily dose of Doxycycline Monohydrate when compared on the basis of AUC estimates. Although Doxycycline Monohydrate impairs the fertility of rats when administered at sufficient dosage, the effect of Doxycycline Monohydrate on human fertility is unknown.

14 CLINICAL STUDIES

The safety and efficacy of Doxycycline Monohydrate in the treatment of only inflammatory lesions (papules and pustules) of rosacea was evaluated in two randomized, placebo-controlled, multi-centered, double-blind, 16-week Phase 3 trials involving 537 subjects (total of 269 subjects on Doxycycline Monohydrate from the two trials) with rosacea (10 to 40 papules and pustules and two or fewer nodules). Pregnant and nursing women, subjects <18 years of age, and subjects with ocular rosacea and/or blepharitis/meibomianitis who require ophthalmologic treatment were excluded from trial. Mean baseline lesion counts were 20 and 21 for Doxycycline Monohydrate and placebo subject groups respectively.

At Week 16, subjects in the Doxycycline Monohydrate group were evaluated using coprimary endpoints of mean reduction in lesion counts and a dichotomized static Investigator’s Global Assessment of Clear or Almost Clear (defined as 1 to 2 small papules or pustules) when compared to the placebo group in both Phase 3 trials.

Subjects treated with Doxycycline Monohydrate did not demonstrate significant improvement in erythema when compared to those treated with placebo.

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16 HOW SUPPLIED/STORAGE AND HANDLING

Doxycycline Monohydrate (beige opaque capsule imprinted with “GLD 40”) containing Doxycycline Monohydrate, USP in an amount equivalent to 40 mg of anhydrous Doxycycline Monohydrate.

Bottle of 30 (NDC 0299-3822-30).

Storage:

All products are to be stored at controlled room temperatures of 15°C - 30°C (59°F - 86°F) and dispensed in tight, light-resistant containers (USP).

Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information)

Patients taking Doxycycline Monohydrate Capsules 40 mg should receive the following information and instructions:

  • It is recommended that Doxycycline Monohydrate not be used by individuals of either gender who are attempting to conceive a child
  • It is recommended that Doxycycline Monohydrate not be used by pregnant or breast feeding women
  • Patients should be advised that pseudomembranous colitis can occur with Doxycycline Monohydrate therapy. If patients develop watery or bloody stools, they should seek medical attention.
  • Patients should be advised that pseudotumor cerebri can occur with Doxycycline Monohydrate therapy. If patients experience headache or blurred vision they should seek medical attention.
  • Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including Doxycycline Monohydrate. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using Doxycycline Monohydrate. If patients need to be outdoors while using Doxycycline Monohydrate, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. Treatment should be discontinued at the first evidence of sunburn.
  • Concurrent use of Doxycycline Monohydrate may render oral contraceptives less effective.
  • Autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with tetracycline-class drugs, including Doxycycline Monohydrate. Symptoms may be manifested by arthralgia, fever, rash and malaise. Patients who experience such symptoms should be cautioned to stop the drug immediately and seek medical help.
  • Patients should be counseled about discoloration of skin, scars, teeth or gums that can arise from Doxycycline Monohydrate therapy.
  • Take Doxycycline Monohydrate exactly as directed. Increasing doses beyond 40 mg every morning may increase the likelihood that bacteria will develop resistance and will not be treatable by other antibacterial drugs in the future.

PATIENT INFORMATION

Doxycycline Monohydrate (Or-RAY-sha)

(doxycycline)

capsules

Read this Patient Information before you start taking Doxycycline Monohydrate and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

What is Doxycycline Monohydrate?

Doxycycline Monohydrate is a tetracycline-class medicine. Doxycycline Monohydrate is a prescription medicine used in adults to treat only pimples or bumps (papules and pustules) caused by a condition called rosacea. Doxycycline Monohydrate does not lessen redness caused by rosacea.

Doxycycline Monohydrate should not be used for the treatment or prevention of infections.

It is not known if Doxycycline Monohydrate is:

- effective for use for longer than 16 weeks.

- safe for use longer than 9 months.

- safe and effective in children. Doxycycline Monohydrate should not be used in infants and children less than 8 years of age because it may cause stained teeth in infants and children.

Who should not take Doxycycline Monohydrate?

Do not take Doxycycline Monohydrate if you are allergic to Doxycycline Monohydrate or other medicines in the tetracycline-class. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

What should I tell my doctor before taking Doxycycline Monohydrate?

Before you take Doxycycline Monohydrate tell your doctor if you:

- have kidney problems.

- have liver problems.

- have diarrhea or watery stools.

- have vision problems.

- have had surgery on your stomach (gastric surgery).

- have or had a yeast or fungal infection in your mouth or vagina.

- have any other medical condition.

- are pregnant or plan to become pregnant. Doxycycline Monohydrate may harm your unborn baby. Taking Doxycycline Monohydrate while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Stop taking Doxycycline Monohydrate and call your doctor right away if you become pregnant while taking Doxycycline Monohydrate.

- are breastfeeding or plan to breastfeed. Doxycycline Monohydrate can pass into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take Doxycycline Monohydrate. You and your doctor should decide if you will take Doxycycline Monohydrate or breastfeed. You should not do both.

You should not take Doxycycline Monohydrate if you are a male with a female sexual partner who plans to become pregnant at any time while you are being treated with Doxycycline Monohydrate.

Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Doxycycline Monohydrate and other medicines can affect each other causing serious side effects.

Especially tell your doctor if you take:

- birth control pills. Doxycycline Monohydrate may reduce the effectiveness of birth control pills. Talk to your doctor about what types of birth control you can use to prevent pregnancy while taking Doxycycline Monohydrate.

- a blood thinner medicine.

- a penicillin (antibacterial medicine).

- proton pump inhibitors or antacids that contain aluminum, calcium, or magnesium.

- products containing iron or bismuth subsalicylate.

- a medicine taken by mouth that contains isotretinoin or acitretin.

- a medicine to treat seizures, such as carbamazepineor or phenytoin.

Ask your doctor or pharmacist for a full list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take Doxycycline Monohydrate?

- Take Doxycycline Monohydrate exactly as prescribed by your doctor. Taking more than your prescribed dose may increase your chance of side effects, including the chance that bacteria will become resistant to Doxycycline Monohydrate.

- Take Doxycycline Monohydrate 1 time a day in the morning on an empty stomach.

- You should take Doxycycline Monohydrate at least one hour before or two hours after a meal.

- Take Doxycycline Monohydrate with enough fluid to completely swallow the capsule and to lower your risk of getting irritation or ulcer in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.

- If you took too much Doxycycline Monohydrate call your doctor right away.

- Your doctor may do blood tests during treatment with Doxycycline Monohydrate to check for side effects.

What should I avoid while taking Doxycycline Monohydrate?

Avoid sunlight or artificial sunlight, such as a tanning booth or sunlamp. You could get severe sunburn. Use sunscreen and wear clothes that cover your skin while out in sunlight.

What are the possible side effects of Doxycycline Monohydrate?

Doxycycline Monohydrate may cause serious side effects, including:

- Harm to an unborn baby. See “What should I tell my doctor before taking Doxycycline Monohydrate?”

- Permanent teeth discoloration. Doxycycline Monohydrate may permanently turn a baby or child's teeth yellow-grey-brown during tooth development. Doxycycline Monohydrate should not be used during tooth development. Tooth development happens in the last half of pregnancy, and from birth to 8 years of age. See “What should I tell my doctor before taking Doxycycline Monohydrate?”

- Intestine infection (pseudomembranous colitis). Pseudomembranous colitis can happen with most antibiotics, including Doxycycline Monohydrate. Call your doctor right away if you get diarrhea or bloody stools.

- Immune system reactions including a lupus-like syndrome, hepatitis,

and inflammation of blood or lymph vessels (vasculitis). Stop taking Doxycycline Monohydrate and tell your doctor right away if you get joint pain, fever, rash, or body weakness.

- Discoloration (hyperpigmentation). Doxycycline Monohydrate can cause darkening of your skin, scars, teeth, gums, nails, and whites of your eyes.

- Benign intracranial hypertension, also called pseudotumor cerebri. This is a condition where there is high pressure in the fluid around the brain. This swelling may lead to vision changes and permanent vision loss. Stop taking Doxycycline Monohydrate and tell your doctor right away if you have blurred vision, vision loss, or unusual headaches.

The most common side effects of Doxycycline Monohydrate include:

- soreness in the nose and throat

- sinus infection

- fungus infection

- flu-like symptoms

- diarrhea

- stomach (abdominal) bloating or pain

- high blood pressure (hypertension)

- change in certain blood tests

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Doxycycline Monohydrate. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137.

How should I store Doxycycline Monohydrate?

- Store Doxycycline Monohydrate at room temperature between 59°F to 86°F (15°C to 30°C).

- Keep Doxycycline Monohydrate in a tightly closed container.

- Keep Doxycycline Monohydrate inside container and out of light.

Keep Doxycycline Monohydrate and all medicine out of the reach of children.

General information about Doxycycline Monohydrate

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take Doxycycline Monohydrate for a condition for which it was not prescribed. Do not give Doxycycline Monohydrate to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Doxycycline Monohydrate. If you would like more information, talk with your doctor. You can also ask your doctor or pharmacist for information that is written for health professionals.

What are the ingredients in Doxycycline Monohydrate?

Active ingredient: Doxycycline Monohydrate

Inactive ingredients: hypromellose, iron oxide red, iron oxide yellow, methacrylic acid copolymer, polyethylene glycol, Polysorbate 80, sugar spheres, talc, titanium dioxide, and triethyl citrate.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Marketed by:

GALDERMA LABORATORIES, L.P.

Fort Worth, Texas 76177 USA

All trademarks are the property of their respective owners.

P52631-0

NDC 0299-3822-30

Doxycycline Monohydrate®

(doxycycline, USP) Capsules

40 mg*

*30 mg immediate release &

10 mg delayed release beads

GALDERMA

30 Capsules

Rx Only

INERT INGREDIENTS:

Hypromellose, Iron Oxide Red, Iron Oxide

Yellow, Methacrylic Acid Copolymer,

Polyethylene Glycol, Polysorbate 80,

Sugar Spheres, Talc, Titanium Dioxide,

and Triethyl Citrate

DOSAGE: ONE CAPSULE PER DAY

Store at controlled room temperature

of 15°C - 30°C (59°F - 86°F).

Keep out of reach of children

Marketed by:

GALDERMA LABORATORIES, L.P.

Fort Worth, Texas 76177 USA

Galderma is a registered trademark.

www.oracea.com

P52630-0

LOT

EXP

Doxycycline Monohydrate available forms, composition, doses:


Indications and Usages:

ATC codes:


ICD-10 codes:


Doxycycline Monohydrate destination | category:


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Drugs with same active ingredients (Pharmaceutical companies):


References

  1. Dailymed."DOXYCYCLINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "doxycycline". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "doxycycline". http://www.drugbank.ca/drugs/DB0025... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Doxycycline Monohydrate?

Depending on the reaction of the Doxycycline Monohydrate after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Doxycycline Monohydrate not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Doxycycline Monohydrate addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Doxycycline Monohydrate, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Doxycycline Monohydrate consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

Visitor reported doses

No survey data has been collected yet

Two visitors reported time for results

What is the time duration Doxycycline Monohydrate drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sdrugs.com website users needed 1 day to notice the result from using Doxycycline Monohydrate drug. The time needed to show improvement in health condition after using the medicine Doxycycline Monohydrate need not be same for all the users. It varies based on other factors.
Visitors%
1 day1
50.0%
1 week1
50.0%

Visitor reported administration

No survey data has been collected yet

One visitor reported age

Visitors%
30-451
100.0%

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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