Drugs List

Therapeutic Indications

Uses

Treatment of moderate to severe acne.

Administration

For oral administration.

To reduce the risk of oesophageal irritation and ulceration, the capsules should be swallowed whole with plenty of fluid, while sitting or standing. Absorption of minocycline is impaired by food.

Absorption of minocycline is impaired by concurrent administration of antacids, iron, calcium, magnesium, aluminium and zinc salts. It is therefore recommended that any indigestion remedies, vitamins, or any other supplement containing these substances are taken at least 3 hours before or after a dose of minocycline.

Contraindications

Pregnancy - see Pregnancy section

Breastfeeding - see Lactation section

Children under 12 years

Renal failure

Precautions and Warnings

Treatment of acne should be continued for a minimum of 6 weeks. If there is no satisfactory response after 6 months of treatment minocycline should be discontinued and other therapies considered.

If treatment exceeds 6 months patients should be monitored at least every 3 months for signs of hepatitis, systemic lupus erythematosus or unusual pigmentation.

Severe renal impairment - see Dosage - Renal Impairment.

Minocycline should be used with caution in patients with hepatic impairment and when used concurrently with alcohol and other hepatotoxic drugs. Alcohol consumption should remain within the Government's recommended limits.

Rare cases of auto-immune hepatotoxicity, systemic lupus erythematosus (SLE), and exacerbation of pre-existing SLE have been reported with minocycline therapy. Treatment should be discontinued if any of these reactions occur.

Tetracyclines may cause weak neuromuscular blockade in patients with myasthenia gravis.

As with other tetracyclines, benign intracranial hypertension has been reported in juveniles and adults receiving minocycline. This effect may present as headache, visual disturbances, scotoma or diplopia. Permanent vision loss has been reported.
Treatment should be discontinued if evidence of raised intracranial pressure develops.

Tetracyclines may cause photosensitivity. Patients should be advised to avoid exposure to natural or artificial light and to discontinue therapy at the first signs of skin discomfort.

Cross-resistance between tetracyclines may develop in micro-organisms and cross-sensitisation in patients. Minocycline should be discontinued if there are signs or symptoms of overgrowth of resistant organisms (such as enteritis, glossitis, stomatitis, vaginitis, pruritus ani or staphylococcal enteritis).

Pulmonary infiltrates and eosinophilia have been reported with minocycline. Patients should be advised to stop taking minocycline and to contact their doctor immediately if they develop breathing difficulties.

The Faculty of Sexual and Reproductive Health has issued revised guidance concerning additional contraceptive cover when antibiotics are prescribed to patients taking combined oral contraceptives in January 2011. With the exception of the enzyme-inducing antibiotics rifampicin and rifabutin, it is no longer necessary to advise the patient to take additional contraceptive precautions while also taking an antibiotic.

Advise the patient that if vomiting occurs, she should follow the guidance for the oral contraceptive in respect of additional doses or contraceptive precautions.

Minocycline may cause hyperpigmentation at various sites across the body, regardless of dose or treatment duration, although it is more common during long term therapy. If this occurs, treatment should be discontinued. Patients should be advised to report any unusual pigmentation.

Tetracyclines may cause permanent tooth discolouration during tooth development in children under 12 years. Enamel hypoplasia has also been reported.

Some formulations contain sunset yellow (E110), which can cause allergic reactions, including asthma.

Absorption of minocycline is impaired by concurrent administration of antacids, iron, calcium, magnesium, aluminium and zinc salts. It is therefore recommended that any indigestion remedies, vitamins, or any other supplement containing these substances are taken at least 3 hours before or after a dose of minocycline.

Patients should be warned that possible adverse effects including headache, light-headedness, dizziness, tinnitus, vertigo, and rarely impaired hearing may effect their ability to drive or operate machinery.

Periodic laboratory evaluations of organ system function, including haematopoietic, renal and hepatic function should be conducted.

Pregnancy and Lactation

Pregnancy

Minocycline is contraindicated during pregnancy.

Animal studies indicate that tetracyclines cross the placenta, are found in foetal tissues, and can have toxic effects on the developing foetus (often effecting skeletal development). Embryotoxicity has also been noted in animals treated early in pregnancy.

A permanent discolouration of the teeth may be observed when administering minocycline after the first trimester. This reaction is more common with long term treatment but has been observed following repeated short term courses. Enamel hypoplasia has also been reported.

The use of tetracyclines, especially in high doses or via intravenous administration in the second half of pregnancy, has also been associated with severe maternal hepatic toxicity.

Schaefer concludes that tetracyclines are contraindicated beyond the 15th week of gestation. In the first trimester, they are considered to be second-line therapy. Doxycycline should be preferred in such cases. Inadvertent use of tetracyclines, even after 15th week is not an indication for termination or invasive prenatal diagnostic procedures.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Minocycline is contraindicated during lactation. Permanent tooth discolouration may occur in the developing infant and enamel hypoplasia has also been reported.

Tetracyclines have been found in human breast milk in low levels. Absorption by the infant is probably inhibited by the calcium in breast milk.

Black discoloration of breast milk has been reported with minocycline.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Oral and anogenital candidiasis
Vulvovaginitis
Eosinophilia
Leucopenia
Neutropenia
Thrombocytopenia
Haemolytic anaemia
Pancytopenia
Agranulocytosis
Anaphylaxis
Anaphylactic shock
Hypersensitivity reactions
Pulmonary infiltration
Anaphylactoid purpura
Thyroid abnormalities
Brown-black microscopic discolouration of thyroid tissue
Anorexia
Dizziness
Headache
Hypaesthesia
Paraesthesia
Intracranial hypertension
Vertigo
Convulsions
Sedation
Hearing disturbances
Tinnitus
Visual disturbances
Myocarditis
Pericarditis
Wheezing
Cough
Dyspnoea
Bronchospasm
Exacerbation of pre-existing asthma
Pulmonary eosinophilia
Pneumonitis
Diarrhoea
Nausea
Stomatitis
Tooth discolouration
Vomiting
Dyspepsia
Dysphagia
Enamel hypoplasia
Enterocolitis
Oesophagitis
Oesophageal ulceration
Glossitis
Pancreatitis
Pseudomembranous colitis
Antibiotic associated colitis
Elevation of liver enzymes
Hepatitis
Autoimmune hepatotoxicity
Cholestatic hepatitis
Hepatic failure
Hyperbilirubinaemia
Jaundice
Alopecia
Erythema multiforme
Erythema nodosum
Fixed drug eruption
Hyperpigmentation of skin
Photosensitivity
Pruritus
Rash
Urticaria
Vasculitis
Angioedema
Exfoliative dermatitis
Pigmentation of nails
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Arthralgia
Lupus erythematosus-like syndrome
Myalgia
Arthritis
Bone discolouration
Exacerbation of systemic lupus erythematosus
Joint stiffness
Joint swelling
Serum urea increased
Renal failure
Interstitial nephritis
Balanitis
Fever
Discolouration of body fluids
Discolouration of conjunctiva
Nephritis
Lymphadenopathy
Positive antinuclear antibody
Serum sickness-like syndrome
Oral cavity discolouration
Polyarteritis nodosa

Presentation

Modified release capsule containing 100mg minocycline (as minocycline hydrochloride).

Drugs List

Therapeutic Indications

Uses

Treatment of moderate to severe acne.

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Additional Dosage Information

Administration

For oral administration.

To reduce the risk of oesophageal irritation and ulceration, the capsules should be swallowed whole with plenty of fluid, while sitting or standing. Absorption of minocycline is impaired by food.

Absorption of minocycline is impaired by concurrent administration of antacids, iron, calcium, magnesium, aluminium and zinc salts. It is therefore recommended that any indigestion remedies, vitamins, or any other supplement containing these substances are taken at least 3 hours before or after a dose of minocycline.

Contraindications

Pregnancy - see Pregnancy section

Breastfeeding - see Lactation section

Children under 12 years

Renal failure

Precautions and Warnings

Treatment of acne should be continued for a minimum of 6 weeks. If there is no satisfactory response after 6 months of treatment minocycline should be discontinued and other therapies considered.

If treatment exceeds 6 months patients should be monitored at least every 3 months for signs of hepatitis, systemic lupus erythematosus or unusual pigmentation.

Severe renal impairment - see Dosage - Renal Impairment.

Minocycline should be used with caution in patients with hepatic impairment and when used concurrently with alcohol and other hepatotoxic drugs. Alcohol consumption should remain within the Government's recommended limits.

Rare cases of auto-immune hepatotoxicity, systemic lupus erythematosus (SLE), and exacerbation of pre-existing SLE have been reported with minocycline therapy. Treatment should be discontinued if any of these reactions occur.

Tetracyclines may cause weak neuromuscular blockade in patients with myasthenia gravis.

As with other tetracyclines, benign intracranial hypertension has been reported in juveniles and adults receiving minocycline. This effect may present as headache, visual disturbances, scotoma or diplopia. Permanent vision loss has been reported.
Treatment should be discontinued if evidence of raised intracranial pressure develops.

Tetracyclines may cause photosensitivity. Patients should be advised to avoid exposure to natural or artificial light and to discontinue therapy at the first signs of skin discomfort.

Cross-resistance between tetracyclines may develop in micro-organisms and cross-sensitisation in patients. Minocycline should be discontinued if there are signs or symptoms of overgrowth of resistant organisms (such as enteritis, glossitis, stomatitis, vaginitis, pruritus ani or staphylococcal enteritis).

Pulmonary infiltrates and eosinophilia have been reported with minocycline. Patients should be advised to stop taking minocycline and to contact their doctor immediately if they develop breathing difficulties.

The Faculty of Sexual and Reproductive Health has issued revised guidance concerning additional contraceptive cover when antibiotics are prescribed to patients taking combined oral contraceptives in January 2011. With the exception of the enzyme-inducing antibiotics rifampicin and rifabutin, it is no longer necessary to advise the patient to take additional contraceptive precautions while also taking an antibiotic.

Advise the patient that if vomiting occurs, she should follow the guidance for the oral contraceptive in respect of additional doses or contraceptive precautions.

Minocycline may cause hyperpigmentation at various sites across the body, regardless of dose or treatment duration, although it is more common during long term therapy. If this occurs, treatment should be discontinued. Patients should be advised to report any unusual pigmentation.

Tetracyclines may cause permanent tooth discolouration during tooth development in children under 12 years. Enamel hypoplasia has also been reported.

Some formulations contain sunset yellow (E110), which can cause allergic reactions, including asthma.

Absorption of minocycline is impaired by concurrent administration of antacids, iron, calcium, magnesium, aluminium and zinc salts. It is therefore recommended that any indigestion remedies, vitamins, or any other supplement containing these substances are taken at least 3 hours before or after a dose of minocycline.

Patients should be warned that possible adverse effects including headache, light-headedness, dizziness, tinnitus, vertigo, and rarely impaired hearing may effect their ability to drive or operate machinery.

Periodic laboratory evaluations of organ system function, including haematopoietic, renal and hepatic function should be conducted.

Pregnancy and Lactation

Pregnancy

Minocycline is contraindicated during pregnancy.

Animal studies indicate that tetracyclines cross the placenta, are found in foetal tissues, and can have toxic effects on the developing foetus (often effecting skeletal development). Embryotoxicity has also been noted in animals treated early in pregnancy.

A permanent discolouration of the teeth may be observed when administering minocycline after the first trimester. This reaction is more common with long term treatment but has been observed following repeated short term courses. Enamel hypoplasia has also been reported.

The use of tetracyclines, especially in high doses or via intravenous administration in the second half of pregnancy, has also been associated with severe maternal hepatic toxicity.

Schaefer concludes that tetracyclines are contraindicated beyond the 15th week of gestation. In the first trimester, they are considered to be second-line therapy. Doxycycline should be preferred in such cases. Inadvertent use of tetracyclines, even after 15th week is not an indication for termination or invasive prenatal diagnostic procedures.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Minocycline is contraindicated during lactation. Permanent tooth discolouration may occur in the developing infant and enamel hypoplasia has also been reported.

Tetracyclines have been found in human breast milk in low levels. Absorption by the infant is probably inhibited by the calcium in breast milk.

Black discoloration of breast milk has been reported with minocycline.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Effects on Ability to Drive and Operate Machinery

Possible adverse effects including headache, light-headedness, dizziness, tinnitus, vertigo, and rarely impaired hearing may effect the ability to drive or operate machinery.

Counselling

Advise patient to avoid antacids or mineral supplements for 3 hours before or after minocycline.

Advise patient to report any unusual pigmentation.

Advise patient of the possibility of photosensitivity.

Advise patient that possible adverse effects including headache, light-headedness, dizziness, tinnitus, vertigo, and rarely impaired hearing may effect their ability to drive or operate machinery.

Side Effects

Oral and anogenital candidiasis
Vulvovaginitis
Eosinophilia
Leucopenia
Neutropenia
Thrombocytopenia
Haemolytic anaemia
Pancytopenia
Agranulocytosis
Anaphylaxis
Anaphylactic shock
Hypersensitivity reactions
Pulmonary infiltration
Anaphylactoid purpura
Thyroid abnormalities
Brown-black microscopic discolouration of thyroid tissue
Anorexia
Dizziness
Headache
Hypaesthesia
Paraesthesia
Intracranial hypertension
Vertigo
Convulsions
Sedation
Hearing disturbances
Tinnitus
Visual disturbances
Myocarditis
Pericarditis
Wheezing
Cough
Dyspnoea
Bronchospasm
Exacerbation of pre-existing asthma
Pulmonary eosinophilia
Pneumonitis
Diarrhoea
Nausea
Stomatitis
Tooth discolouration
Vomiting
Dyspepsia
Dysphagia
Enamel hypoplasia
Enterocolitis
Oesophagitis
Oesophageal ulceration
Glossitis
Pancreatitis
Pseudomembranous colitis
Antibiotic associated colitis
Elevation of liver enzymes
Hepatitis
Autoimmune hepatotoxicity
Cholestatic hepatitis
Hepatic failure
Hyperbilirubinaemia
Jaundice
Alopecia
Erythema multiforme
Erythema nodosum
Fixed drug eruption
Hyperpigmentation of skin
Photosensitivity
Pruritus
Rash
Urticaria
Vasculitis
Angioedema
Exfoliative dermatitis
Pigmentation of nails
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Arthralgia
Lupus erythematosus-like syndrome
Myalgia
Arthritis
Bone discolouration
Exacerbation of systemic lupus erythematosus
Joint stiffness
Joint swelling
Serum urea increased
Renal failure
Interstitial nephritis
Balanitis
Fever
Discolouration of body fluids
Discolouration of conjunctiva
Nephritis
Lymphadenopathy
Positive antinuclear antibody
Serum sickness-like syndrome
Oral cavity discolouration
Polyarteritis nodosa

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Shelf Life and Storage

Do not store above 25 degrees C

Store in the original container, protected from light.

Further Information

Last Full Review Date: May 2012.

Reference Sources

British National Formulary, 63rd Edition (2012) Pharmaceutical Press, London.

BNF for Children (2011-2012) Pharmaceutical Press, London.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Summary of Product Characteristics: Minocin MR 100mg Modified Release Capsules. Meda Pharmaceuticals. Revised August 2010.
Summary of Product Characteristics: Sebomin 100mg MR Capsules. Actavis UK. Revised September 2011.

Faculty of Sexual and Reproductive Healthcare
https://www.ffprhc.org.uk/pdfs/CEUGuidanceDrugInteractionsHormonal.pdf
Last accessed 31 May 2011

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Minocycline. Last revised: December 7, 2010
Last accessed: May 15, 2012