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VIBRAMYCIN D DISPERSIBLE TABLETS 100MG

Active substance(s): DOXYCYCLINE / DOXYCYCLINE / DOXYCYCLINE

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SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT
Vibramycin-D 100 mg Dispersible Tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
l00 mg doxycycline as doxycycline monohydrate.
For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM
Dispersible Tablets.
Vibramycin-D Dispersible Tablets are light yellow, round tablets scored on one face and
coded ‘VN’ on the other.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Vibramycin has been found clinically effective in the treatment of a variety of infections caused
by susceptible strains of Gram-positive and Gram-negative bacteria and certain other microorganisms.
Respiratory tract infections Pneumonia and other lower respiratory tract infections due to
susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella
pneumoniae and other organisms. Mycoplasma pneumoniae. Treatment of chronic bronchitis,
sinusitis.
Urinary tract infections caused by susceptible strains of Klebsiella species, Enterobacter
species, Escherichia coli, Streptococcus faecalis and other organisms.
Sexually transmitted diseases Infections due to Chlamydia trachomatis including
uncomplicated urethral, endocervical or rectal infections. Non-gonococcal urethritis caused by
Ureaplasma urealyticum (T-mycoplasma). Vibramycin is also indicated in chancroid,
granuloma inguinale and lymphogranuloma venereum. Vibramycin is an alternative drug in the
treatment of gonorrhoea and syphilis.
Skin infections Acne vulgaris, when antibiotic therapy is considered necessary.
Since Vibramycin is a member of the tetracycline series of antibiotics, it may be expected to be
useful in the treatment of infections which respond to other tetracyclines, such as:

Ophthalmic infections Due to susceptible strains of gonococci, staphylococci and Haemophilus
influenzae. Trachoma, although the infectious agent, as judged by immunofluorescence, is not
always eliminated. Inclusion conjunctivitis may be treated with oral Vibramycin alone or in
combination with topical agents.
Rickettsial infections Rocky Mountain spotted fever, typhus group, Q fever, Coxiella
endocarditis and tick fevers.
Other infections Psittacosis, brucellosis (in combination with streptomycin), cholera, bubonic
plague, louse and tick-borne relapsing fever, tularaemia glanders, melioidosis, chloroquineresistant falciparum malaria and acute intestinal amoebiasis (as an adjunct to amoebicides).
Vibramycin is an alternative drug in the treatment of leptospirosis, gas gangrene and tetanus.
Vibramycin is indicated for prophylaxis in the following conditions: Scrub typhus, travellers’
diarrhoea (enterotoxigenic Escherichia coli), leptospirosis and malaria. Prophylaxis of malaria
should be used in accordance to current guidelines, as resistance is an ever changing problem.
4.2

Posology and method of administration
Posology

Adults
The usual dosage of Vibramycin for the treatment of acute infections in adults is 200 mg on the
first day (as a single dose or in divided doses) followed by a maintenance dose of 100 mg/day.
In the management of more severe infections, 200 mg daily should be given throughout
treatment.

Dosage recommendations in specific infections:
Acne vulgaris 50 mg daily with food or fluid for 6 to 12 weeks.
Sexually transmitted diseases 100 mg twice daily for 7 days is recommended in the following
infections: uncomplicated gonococcal infections (except anorectal infections in men);
uncomplicated urethral, endocervical or rectal infection caused by Chlamydia trachomatis; nongonococcal urethritis caused by Ureaplasma urealyticum. Acute epididymo-orchitis caused by
Chlamydia trachomatis or Neisseria gonorrhoea 100 mg twice daily for 10 days. Primary and
secondary syphilis: Non-pregnant penicillin-allergic patients who have primary or secondary
syphilis can be treated with the following regimen: doxycycline 200 mg orally twice daily for
two weeks, as an alternative to penicillin therapy.
Louse and tick-borne relapsing fevers A single dose of 100 or 200 mg according to severity.
Treatment of chloroquine-resistant falciparum malaria 200 mg daily for at least 7 days. Due
to the potential severity of the infection, a rapid-acting schizonticide such as quinine should
always be given in conjunction with Vibramycin; quinine dosage recommendations vary in
different areas.
Prophylaxis of malaria 100 mg daily in adults and children over the age of 12 years.
Prophylaxis can begin 1-2 days before travel to malarial areas. It should be continued daily
during travel in the malarial areas and for 4 weeks after the traveller leaves the malarial area.

For current advice on geographical resistance patterns and appropriate chemoprophylaxis,
current guidelines or the Malaria Reference Laboratory should be consulted, details of which
can be found in the British National Formulary (BNF).
For the prevention of scrub typhus 200 mg as a single dose.
For the prevention of travellers’ diarrhoea in adults 200 mg on the first day of travel
(administered as a single dose or as 100 mg every 12 hours) followed by 100 mg daily
throughout the stay in the area. Data on the use of the drug prophylactically are not available
beyond 21 days.
For the prevention of leptospirosis 200 mg once each week throughout the stay in the area and
200 mg at the completion of the trip. Data on the use of the drug prophylactically are not
available beyond 21 days.
Paediatric population See section 4.3.
Use in the elderly Vibramycin may be prescribed in the elderly in the usual dosages with no
special precautions. No dosage adjustment is necessary in the presence of renal impairment. The
Vibramycin-D dispersible tablet may be preferred for the elderly since it is less likely to be
associated with oesophageal irritation and ulceration.
Use in patients with impaired hepatic function See section 4.4.
Use in patients with renal impairment Studies to date have indicated that administration of
Vibramycin at the usual recommended doses does not lead to accumulation of the antibiotic in
patients with renal impairment see section 4.4.
Method of administration
Dispersible Tablets are for oral administration only.
Vibramycin-D tablets are administered by drinking a suspension of the tablets in a small amount
of water. This should be done in the sitting or standing position and well before retiring at night
to reduce the risk of oesophageal irritation and ulceration. If gastric irritation occurs, it is
recommended that Vibramycin be given with food or milk. Studies indicate that the absorption
of Vibramycin is not notably influenced by simultaneous ingestion of food or milk.
Exceeding the recommended dosage may result in an increased incidence of side effects.
Therapy should be continued for at least 24 to 48 hours after symptoms and fever have
subsided.
When used in streptococcal infections, therapy should be continued for 10 days to prevent the
development of rheumatic fever or glomerulonephritis.
4.3

Contraindications
Hypersensitivity to doxycycline or to any of the tetracyclines or to any of the excipients listed
in section 6.1.
The use of drugs of the tetracycline class during tooth development (pregnancy, infancy and
childhood to the age of 12 years) may cause permanent discolouration of the teeth (yellow-greybrown). This adverse reaction is more common during long-term use of the drugs but has been
observed following repeated short-term courses. Enamel hypoplasia has also been reported.
Vibramycin is therefore contraindicated in these groups of patients.

Pregnancy Vibramycin is contraindicated in pregnancy. It appears that the risks associated with
the use of tetracyclines during pregnancy are predominantly due to effects on teeth and skeletal
development. (See above about use during tooth development).
Nursing mothers Tetracyclines are excreted into milk and are therefore contraindicated in
nursing mothers. (See above about use during tooth development).
Paediatric population Vibramycin is contraindicated in children under the age of 12 years. As
with other tetracyclines, Vibramycin forms a stable calcium complex in any bone-forming
tissue. A decrease in the fibula growth rate has been observed in prematures given oral
tetracyclines in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible
when the drug was discontinued. (See above about use during tooth development).
4.4

Special warnings and precautions for use
Use in patients with impaired hepatic function Vibramycin should be administered with
caution to patients with hepatic impairment or those receiving potentially hepatotoxic drugs.
Abnormal hepatic function has been reported rarely and has been caused by both the oral and
parenteral administration of tetracyclines, including doxycycline.
Use in patients with renal impairment Excretion of doxycycline by the kidney is about
40%/72 hours in individuals with normal renal function. This percentage excretion may fall to a
range as low as 1-5%/72 hours in individuals with severe renal insufficiency (creatinine
clearance below 10ml/min). Studies have shown no significant difference in the serum half-life
of doxycycline in individuals with normal and severely impaired renal function. Haemodialysis
does not alter the serum half-life of doxycycline. The anti-anabolic action of the tetracyclines
may cause an increase in blood urea. Studies to date indicate that this anti-anabolic effect does
not occur with the use of Vibramycin in patients with impaired renal function.
Serious skin reactions Serious skin reactions, such as exfoliative dermatitis, erythema
multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with
eosinophilia and systemic symptoms (DRESS) have been reported in patients receiving
doxycycline (see section 4.8). If serious skin reactions occur, doxycycline should be
discontinued immediately and appropriate therapy should be instituted.
Photosensitivity Photosensitivity manifested by an exaggerated sunburn reaction has been
observed in some individuals taking tetracyclines, including doxycycline (see section 4.8).
Patients likely to be exposed to direct sunlight or ultraviolet light should be advised that this
reaction can occur with tetracycline drugs and treatment should be discontinued at the first
evidence of skin erythema.
Photoonycholysis has also been reported in patients receiving doxycycline (see section 4.8).
Benign intracranial hypertension Bulging fontanelles in infants have been reported in
individuals receiving tetracyclines. Benign intracranial hypertension (pseudotumor cerebri)
has been associated with the use of tetracyclines including doxycycline. Benign intracranial
hypertension (pseudotumor cerebri) is usually transient, however cases of permanent visual
loss secondary to benign intracranial hypertension (pseudotumor cerebri) have been reported
with tetracyclines including doxycycline. If visual disturbance occurs during treatment,
prompt ophthalmologic evaluation is warranted. Since intracranial pressure can remain
elevated for weeks after drug cessation patients should be monitored until they stabilize.
Concomitant use of isotretinoin or other systemic retinoids and doxycycline should be
avoided because isotretinoin is also known to cause benign intracranial hypertension
(pseudotumor cerebri). (See section 4.5).

Microbiological overgrowth The use of antibiotics may occasionally result in the overgrowth of
non-susceptible organisms including Candida. If a resistant organism appears, the antibiotic
should be discontinued and appropriate therapy instituted.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including
doxycycline, and has ranged in severity from mild to life-threatening. It is important to consider
this diagnosis in patients who present with diarrhoea subsequent to the administration of
antibacterial agents.
Clostridium difficile associated diarrhoea (CDAD) has been reported with use of nearly all
antibacterial agents, including doxycycline, and may range in severity from mild diarrhoea 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 diarrhoea following antibiotic use. Careful
medical history is necessary since CDAD has been reported to occur over two months after the
administration of antibacterial agents.
Oesophagitis Instances of oesophagitis and oesophageal ulcerations have been reported in
patients receiving capsule and tablet forms of drugs in the tetracycline class, including
doxycycline. Most of these patients took medications immediately before going to bed or with
inadequate amounts of fluid.
Porphyria There have been rare reports of porphyria in patients receiving tetracyclines.
Venereal disease When treating venereal disease, where co-existent syphilis is suspected,
proper diagnostic procedures including dark-field examinations should be utilised. In all such
cases monthly serological tests should be made for at least four months.
Beta-haemolytic streptococci infections Infections due to group A beta-haemolytic streptococci
should be treated for at least 10 days.
Myasthenia gravis Due to a potential for weak neuromuscular blockade, care should be taken in
administering tetracyclines to patients with myasthenia gravis.
Systemic lupus erythematosus Tetracyclines can cause exacerbation of SLE.
Methoxyflurane Caution is advised in administering tetracyclines with methoxyflurane. See
section 4.5.
4.5

Interaction with other medicinal products and other forms of interaction
The absorption of doxycycline may be impaired by concurrently administered antacids
containing aluminium, calcium, magnesium or other drugs containing these cations; oral zinc,
iron salts or bismuth preparations. Dosages should be maximally separated.
Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable
to avoid giving Vibramycin in conjunction with penicillin.
There have been reports of prolonged prothrombin time in patients taking warfarin and
doxycycline. Tetracyclines depress plasma prothrombin activity and reduced doses of
concomitant anticoagulants may be necessary.

The serum half-life of doxycycline may be shortened when patients are concurrently receiving
barbiturates, carbamazepine or phenytoin. An increase in the daily dosage of Vibramycin
should be considered.
Alcohol may decrease the half-life of doxycycline.
A few cases of pregnancy or breakthrough bleeding have been attributed to the concurrent use
of tetracycline antibiotics with oral contraceptives.
Doxycycline may increase the plasma concentration of ciclosporin. Co-administration should
only be undertaken with appropriate monitoring.
The concurrent use of tetracyclines and methoxyflurane has been reported to result in fatal renal
toxicity. See section 4.4.
Concomitant use of isotretinoin or other systemic retinoids and doxycycline should be avoided.
Each of these agents used alone has been associated with benign intracranial hypertension
(pseudotumor cerebri). (See section 4.4).
Laboratory test interactions
False elevations of urinary catecholamine levels may occur due to interference with the
fluorescence test.

4.6

Fertility, pregnancy and lactation
See section 4.3.

4.7

Effects on ability to drive and use machines
The effect of doxycycline on the ability to drive or operate heavy machinery has not
been studied. There is no evidence to suggest that doxycycline may affect these
abilities.

4.8

Undesirable effects
The following adverse reactions have been observed in patients receiving tetracyclines,
including doxycycline.

System Organ
Class
Infections and
infestations
Blood and
lymphatic system
disorders

Common

≥1/100 to <1/10

Uncommon

≥1/1000 to <1/100
Vaginal infection

Rare

≥1/10,000 to <1/1000
Candida Infection
Haemolytic anaemia,
neutropenia,
thrombocytopenia,
eosinophilia

System Organ
Class
Immune system
disorders

Endocrine
disorders
Metabolism and
nutrition
disorders
Nervous system
disorders
Ear and labyrinth
disorders
Vascular
disorders
Gastrointestinal
disorders

Common

≥1/100 to <1/10
Anaphylactic reaction
(including angioedema,
exacerbation of systemic
lupus erythematosus,
pericarditis,
hypersensitivity, serum
sickness, HenochSchonlein purpura,
hypotension, dyspnoea,
tachycardia, peripheral
oedema and urticaria)

Musculoskeletal,
connective tissue
and bone
disorders
Renal and urinary
disorders

Rare

≥1/10,000 to <1/1000
Drug Reaction with
Eosinophilia and Systemic
Symptoms (DRESS)

Brown-black microscopic
discoloration of thyroid glands
Porphyria, decreased appetite

Headache

Benign intracranial
hypertension (pseudotumor
cerebri)*, fontanelle bulging
Tinnitus
Flushing

Nausea/vomiting

Hepatobiliary
disorders
Skin and
subcutaneous
tissue disorders

Uncommon

≥1/1000 to <1/100

Photosensitivity reaction,
rash including
maculopapular and
erythematous rashes

Dyspepsia
(Heartburn/gastritis)

Pancreatitis,
pseudomembranous colitis,
Clostridium difficile colitis,
oesophageal ulcer,
oesophagitis, enterocolitis,
inflammatory lesions (with
monilial overgrowth) in the
anogenital region, dysphagia,
abdominal pain, diarrhoea,
glossitis, stomatitis
Hepatic failure, hepatitis,
hepatotoxicity, jaundice,
hepatic function abnormal
Toxic epidermal necrolysis,
Stevens-Johnson syndrome,
erythema multiforme,
dermatitis exfoliative,
photoonycholysis
Arthralgia, myalgia

Blood urea increased

* Symptoms included blurring of vision, scotomata and diplopia. Permanent visual loss has been reported.

Tetracyclines may cause discoloration of teeth and enamel hypoplasia, but usually only after long-term
use.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow
Card Scheme at www.mhra.gov.uk/yellowcard.

4.9

Overdose
Acute overdosage with antibiotics is rare. In the event of overdosage discontinue
medication. Gastric lavage plus appropriate supportive treatment is indicated.
Dialysis does not alter serum half-life and thus would not be of benefit in treating
cases of overdosage.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Tetracyclines, ATC code: J01 AA02.
Vibramycin is primarily bacteriostatic and is believed to exert its antimicrobial effect by the
inhibition of protein synthesis. Vibramycin is active against a wide range of Gram-positive
and Gram-negative bacteria and certain other micro-organisms.

5.2.

Pharmacokinetic Properties
Tetracyclines are readily absorbed and are bound to plasma proteins in varying
degrees. They are concentrated by the liver in the bile and excreted in the urine and
faeces at high concentrations and in a biologically active form. Doxycycline is
virtually completely absorbed after oral administration. Studies reported to date
indicate that the absorption of doxycycline, unlike certain other tetracyclines, is not
notably influenced by the ingestion of food or milk. Following a 200mg dose, normal
adult volunteers averaged peak serum levels of 2.6 micrograms/ml of doxycycline at 2
hours decreasing to 1.45 micrograms/ml at 24 hours. Doxycycline has a high degree
of lipid solubility and a low affinity for calcium. It is highly stable in normal human
serum. Doxycycline will not degrade into an epianhydro form.

5.3.

Preclinical Safety Data
None stated

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Anhydrous colloidal silica
Microcrystalline cellulose
Magnesium Stearate

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
4 years.

6.4

Special precautions for storage
Store below 25°C.

6.5

Nature and contents of container
Aluminium/PVC blister strips, a single strip of 8 tablets in a carton box.

6.6

Special precautions for disposal and other handling
No special requirements.

7.

MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 00057/0188

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 29 October 2000
Date of latest renewal: 15 December 2008

10

DATE OF REVISION OF THE TEXT

13/12/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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