Achromycin V

Name: Achromycin V

Other uses for this medicine

Tetracycline is also sometimes used to treat Lyme disease and malaria, and to prevent plague and tularemia in people who have been exposed to plague or tularemia germs. Talk to your doctor about the risks of using this medication for your condition.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Brand names

  • Achromycin V®
  • Sumycin®

Indications and Usage for Achromycin V

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Achromycin V (Tetracycline HCl Capsules, USP) and other antibacterial drugs, Achromycin V (Tetracycline HCl Capsules, USP) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Achromycin V (Tetracycline HCl Capsules, USP) is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:

  • Upper respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae and Hemophilus influenzae. Note: Achromycin V (Tetracycline HCl Capsules, USP) should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible.
  • Lower respiratory tract infections caused by Streptococcus pyogenes, Streptococcus pneumoniae, Mycoplasma pneumoniae (Eaton agent, and Klebsiella sp.)
  • Skin and soft tissue infections caused by Streptococcus pyogenes, Staphylococcus aureaus. (Tetracyclines are not the drugs of choice in the treatment of any type of staphylococcalinfections.)
  • Infections caused by rickettsia including Rocky Mountain spotted fever, typhus group infections, Q fever, rickettsialpox.
  • Psittacosis of ornithosis caused by Chlamydia Psittaci.
  • Infections caused by Chlamydia trachomatis such as uncomplicated urethral, endocervical or rectal infections, inclusion conjunctivitis, trachoma, and lymphogranuloma venereum.
  • Granuloma inquinale caused by Calymmatobacterium granulomatis.
  • Relapsing fever caused by Borrelia sp.
  • Bartonellosis caused by Bartonella bacilliformis.
  • Chancroid caused by Hemophilus ducreyi.
  • Tularemia caused by Francisella tularensis.
  • Plaque caused by Yersinia pestis.
  • Cholera caused by Vibrio cholerae.
  • Brucellosis caused by Brucellaspecies (tetracycline may be used in conjunction with an aminoglycoside).
  • Infections due to Campylobacter fetus.
  • As adjunctive therapy in intestinal amebiasis caused by Entamoeba histolytica.
  • Urinary tract infections caused by susceptible strains of Escherichia coli, Klebsiella, etc.
  • Other infections caused by susceptible gram-negative organisms such as E. coli, Enterobacter aerogenes, Shigellasp., Acinetobacter sp., Klebsiella sp., and Bacteroides sp.
  • In severe acne, adjunctive therapy with Achromycin V (Tetracycline HCl Capsules, USP) may be useful.

When penicillin is contraindicated, tetracyclines are alternative drugs in the treatment of the following infections:

  • Syphilis and yaws caused by Treponema pallidum and pertenue, respectively,
  • Vincent’s infection caused by Fusobacterium fusiforme,
  • Infections caused by Neisseria gonorrhoeae,
  • Anthrax caused by Bacillus anthracis,
  • Infections due to Listeria monocytogenes,
  • Actinomycosis caused by Actinomyces species,
  • Infections due to Clostridium species.

Contraindications

This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

How is Achromycin V Supplied

Achromycin V (Tetracycline HCl Capsules, USP) are available as:

250 mg: Light Blue Opaque Cap/Yellow Opaque Body, Cap and Body Imprinted HP 17 in Black Ink.

Available in bottles of:

100 NDC 23155-487-01

1000 NDC 23155-487-10

500 mg: Light Blue Opaque Cap/Yellow Opaque Body, Cap and Body Imprinted HP 18 in Black Ink.

Available in bottles of:

100 NDC 23155-488-01

500 NDC 23155-488-05

Dispense in a tight, light-resistant containers as defined in the USP. Use child-resistant closure (as required).

Store at 20°to 25°C (68°to 77°F) [See USP Controlled Room Temperature].

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Package label.principal display panel

Achromycin V (Tetracycline HCl Capsules, USP)

250 mg, 100 count label

Achromycin V (Tetracycline HCl Capsules, USP)

500 mg, 100 count label

Achromycin V 
tetracycline hcl capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:23155-487
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRACYCLINE HYDROCHLORIDE (TETRACYCLINE) TETRACYCLINE HYDROCHLORIDE 250 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE  
LIGHT MINERAL OIL  
MAGNESIUM STEARATE  
D&C YELLOW NO. 10  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 6  
GELATIN  
TITANIUM DIOXIDE  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
SHELLAC  
PROPYLENE GLYCOL  
BUTYL ALCOHOL  
Product Characteristics
Color YELLOW (body) , BLUE (cap) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code HP;17
Contains     
Packaging
# Item Code Package Description
1 NDC:23155-487-01 100 CAPSULE (BOTTLE) in 1 BOTTLE
2 NDC:23155-487-10 1000 CAPSULE (BOTTLE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050278 10/18/2013
Achromycin V 
tetracycline hcl capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:23155-488
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRACYCLINE HYDROCHLORIDE (TETRACYCLINE) TETRACYCLINE HYDROCHLORIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE  
LIGHT MINERAL OIL  
MAGNESIUM STEARATE  
D&C YELLOW NO. 10  
FD&C BLUE NO. 1  
FD&C YELLOW NO. 6  
GELATIN  
TITANIUM DIOXIDE  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
SHELLAC  
PROPYLENE GLYCOL  
BUTYL ALCOHOL  
Product Characteristics
Color YELLOW (body) , BLUE (cap) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code HP;18
Contains     
Packaging
# Item Code Package Description
1 NDC:23155-488-01 100 CAPSULE (BOTTLE) in 1 BOTTLE
2 NDC:23155-488-05 500 CAPSULE (BOTTLE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050278 10/18/2013
Labeler - Heritage Pharmaceuticals Inc. (780779901)
Establishment
Name Address ID/FEI Operations
Emcure Pharmaceuticals USA Inc. 189630168 MANUFACTURE(23155-487, 23155-488)
Revised: 06/2014   Heritage Pharmaceuticals Inc.

Description

Tetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetracycline is very slightly soluble in water, freely soluble in dilute acid and in alkali hydroxide solutions, sparingly soluble in alcohol, and practically insoluble in chloroform and in ether. The chemical name for tetracycline hydrochloride is 4-(Dimethylamino)1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,-12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is as follows:


C22H24N208•HCI     M.W. 480.90

Each capsule, for oral administration, contains 250 mg or 500 mg tetracycline hydrochloride.

Inactive Ingredients: Lactose, light mineral oil, and magnesium stearate.

The 250 mg and 500 mg capsule shells contain D&C yellow no. 10, FD&C blue no. 1, FD&C yellow no. 6, gelatin, and titanium dioxide.

The imprinting ink for the 250 mg and 500 mg capsules contains D&C yellow #10, FD&C blue no. 1, FD&C blue no. 2, FD&C red no. 40, iron oxide black, pharmaceutical shellac glaze, propylene glycol and n-butyl alcohol.

Patient information

Patients should be counseled that antibacterial drugs including Achromycin V (Tetracycline HCl Capsules, USP) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Achromycin V (Tetracycline HCl Capsules, USP) is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Achromycin V (Tetracycline HCl Capsules, USP) or other antibacterial drugs in the future.

Dosing & Uses

Dosage Forms & Strengths

capsule/tablet

  • 250mg
  • 500mg

syrup (extemporaneously prepared)

  • 125mg/5mL

Chronic Bronchitis, Acute Exacerbation

500 mg PO q6hr

Acne

250-500 mg PO q12hr

Ehrlichiosis

500 mg PO q6hr for 7-14 days

Vibrio Cholera

500 mg PO q6hr for 3 days

Malaria, Severe Treatment (Unlabeled)

500 mg PO q6hr for 7 days with quinidine gluconate

Dosage Modifications

Renal impairment

  • CrCl 50-80 mL/min: Dose frequency q8-12hr
  • CrCl 10-50 mL/min: Dose frequency q12-24hr
  • CrCl <10 mL/min: Dose frequency q24hr

Dosing Considerations

Susceptible organisms

  • Acinetobacter spp, Actinomyces israelii, Afipia felis, Bacillus anthracis, Bacteroides spp, Bartonella bacilliformis, Bartonella quintana, Bordetella pertussis, Borrelia recurrentis, Brucella spp, Capnocytophaga canimorsus, Campylobacter jejuni, Chlamydia spp, Citrobacter spp, Coxiella burnetii, Eikenella corrodens, Escherichia coli, Francisella tularensis, Leptospira interrogans, Helicobacter pylori, Klebsiella spp, Listeria monocytogenes, Moraxella catarrhalis, Mycoplasma pneumoniae, Neisseria gonorrhoeae, Propionibacterium acnes, Rickettsiae, Shigella spp, Staphylococcus aureus, Streptococcus pneumoniae, Treponema pallidum, Ureaplasma urealyticum, Vibrio cholerae, Yersinia pestis, Yersinia enterocolitica, Yersinia pseudotuberculosis

Dosage Forms & Strengths

capsule/tablet

  • 250mg
  • 500mg

syrup

  • 125mg/5mL

General Dosing Guidelines

<8 years: Not recommended; tooth discoloration and enamel hypoplasia may occur with use in young children

>8 years: 25-50 mg/kg/day PO divided q6hr; not to exceed 3 g/day 

Malaria, Severe Treatment (Unlabeled)

<8 years: Not recommended; tooth discoloration and enamel hypoplasia may occur with use in young children

>8 years: 25-50 mg/kg/day PO divided q6hr, not to exceed 250 mg/dose q6hr for 7 days with quinidine gluconate 

Vibrio Cholera

Single dose: 25 mg/kg PO; not to exceed 1 g/dose  

Multiple dose: 40 mg/kg/day PO divided q6hr for 3 days; not to exceed 2 g/day

Administration

Take on empty stomach; do not take with dairy products

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