Ticar

Name: Ticar

Before Using Ticar

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Many penicillins have been used in children and, in effective doses, are not expected to cause different side effects or problems in children than they do in adults.

Some strengths of the chewable tablets of amoxicillin contain aspartame, which is changed by the body to phenylalanine, a substance that is harmful to patients with phenylketonuria.

Geriatric

Penicillins have been used in the elderly and have not been shown to cause different side effects or problems in older people than they do in younger adults.

Pregnancy

Penicillins have not been studied in pregnant women. However, penicillins have been widely used in pregnant women and have not been shown to cause birth defects or other problems in animal studies.

Breast Feeding

Penicillins pass into the breast milk. Even though only small amounts may pass into breast milk, allergic reactions, diarrhea, fungus infections, and skin rash may occur in nursing babies.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Axitinib
  • Bupropion
  • Chlortetracycline
  • Cholera Vaccine, Live
  • Clarithromycin
  • Cyclosporine
  • Daclatasvir
  • Darunavir
  • Deflazacort
  • Demeclocycline
  • Donepezil
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Doxycycline
  • Elbasvir
  • Etonogestrel
  • Grazoprevir
  • Lymecycline
  • Meclocycline
  • Methacycline
  • Methotrexate
  • Minocycline
  • Nifedipine
  • Olaparib
  • Oxytetracycline
  • Piperaquine
  • Rolitetracycline
  • Simeprevir
  • Tetracycline
  • Vancomycin
  • Vecuronium
  • Velpatasvir
  • Venetoclax
  • Venlafaxine
  • Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy, general (such as asthma, eczema, hay fever, hives), history of—Patients with a history of general allergies may be more likely to have a severe reaction to penicillins
  • Bleeding problems, history of—Patients with a history of bleeding problems may be more likely to have bleeding when receiving carbenicillin, piperacillin, or ticarcillin
  • Congestive heart failure (CHF) or
  • High blood pressure—Large doses of carbenicillin or ticarcillin may make these conditions worse, because these medicines contain a large amount of salt
  • Cystic fibrosis—Patients with cystic fibrosis may have an increased chance of fever and skin rash when receiving piperacillin
  • Kidney disease—Patients with kidney disease may have an increased chance of side effects
  • Mononucleosis (”mono”)—Patients with mononucleosis may have an increased chance of skin rash when receiving ampicillin, bacampicillin, or pivampicillin
  • Phenylketonuria—Some strengths of the amoxicillin chewable tablets contain aspartame, which is changed by the body to phenylalanine, a substance that is harmful to patients with phenylketonuria.
  • Stomach or intestinal disease, history of (especially colitis, including colitis caused by antibiotics)—Patients with a history of stomach or intestinal disease may be more likely to develop colitis while taking penicillins

Ticar Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Less common
  • Fast or irregular breathing
  • fever
  • joint pain
  • lightheadedness or fainting (sudden)
  • puffiness or swelling around the face
  • red, scaly skin
  • shortness of breath
  • skin rash, hives, itching

Check with your doctor immediately if any of the following side effects occur:

Rare
  • Abdominal or stomach cramps and pain (severe)
  • abdominal tenderness
  • convulsions (seizures)
  • decreased amount of urine
  • diarrhea (watery and severe), which may also be bloody
  • mental depression
  • nausea and vomiting
  • pain at place of injection
  • sore throat and fever
  • unusual bleeding or bruising
  • yellow eyes or skin
Rare - For penicillin G procaine only
  • Agitation or combativeness
  • anxiety
  • confusion
  • fear of impending death
  • feeling, hearing, or seeing things that are not real

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Diarrhea (mild)
  • headache
  • sore mouth or tongue
  • vaginal itching and discharge
  • white patches in the mouth and/or on the tongue

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Indications

Ticar is indicated for the treatment of the following infections:

Bacterial septicemia‡

Skin and soft-tissue infections‡

Acute and chronic respiratory tract infections‡§

‡ Caused by susceptible strains of Pseudomonas aeruginosa, Proteus species (both indole-positive and indole-negative) and Escherichia coli.

§ Though clinical improvement has been shown, bacteriological cures cannot be expected in patients with chronic respiratory disease or cystic fibrosis.

Genitourinary tract infections (complicated and uncomplicated) due to susceptible strains of Pseudomonas aeruginosa, Proteus species (both indole-positive and indole-negative), Escherichia coli, Enterobacter and Streptococcus faecalis (enterococcus).

Ticarcillin is also indicated in the treatment of the following infections due to susceptible anaerobic bacteria:

  1. Bacterial septicemia.
  2. Lower respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess.
  3. Intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract).
  4. Infections of the female pelvis and genital tract, such as endometritis, pelvic inflammatory disease, pelvic abscess and salpingitis.
  5. Skin and soft-tissue infections.

Although Ticarcillin is primarily indicated in gram-negative infections, its in vitro activity against gram-positive organisms should be considered in treating infections caused by both gram-negative and gram-positive organisms (see Microbiology).

Based on the in vitro synergism between Ticarcillin and gentamicin sulfate, tobramycin sulfate or amikacin sulfate against certain strains of Pseudomonas aeruginosa, combined therapy has been successful, using full therapeutic dosages. (For additional prescribing information, see the gentamicin sulfate, tobramycin sulfate and amikacin sulfate package inserts.)

NOTE: Culturing and susceptibility testing should be performed initially and during treatment to monitor the effectiveness of therapy and the susceptibility of the bacteria.

Precautions

Although Ticar exhibits the characteristic low toxicity of the penicillins, as with any other potent agent, it is advisable to check periodically for organ system dysfunction (including renal, hepatic and hematopoietic) during prolonged treatment. If overgrowth of resistant organisms occurs, the appropriate therapy should be initiated.

Since the theoretical sodium content is 5.2 mEq (120 mg) per gram of Ticarcillin, and the actual vial content can be as high as 6.5 mEq/gram, electrolyte and cardiac status should be monitored carefully.

In a few patients receiving intravenous Ticarcillin, hypokalemia has been reported. Serum potassium should be measured periodically, and, if necessary, corrective therapy should be implemented.

As with any penicillin, the possibility of an allergic response, including anaphylaxis, exists, particularly in hypersensitive patients.

Usage During Pregnancy

Reproduction studies have been performed in mice and rats and have revealed no evidence of impaired fertility or harm to the fetus due to Ticarcillin. There are no well-controlled studies in pregnant women, but investigational experience does not include any positive evidence of adverse effects on the fetus. Although there is no clearly defined risk, such experience cannot exclude the possibility of infrequent or subtle damage to the fetus. Ticarcillin should be used in pregnant women only when clearly needed.

Ticar Dosage and Administration

Clinical experience indicates that in serious urinary tract and systemic infections, intravenous therapy in the higher doses should be used. Intramuscular injections should not exceed 2 grams per injection.

Adults

Bacterial septicemia

200 to 300 mg/kg/day by I.V. infusion in divided doses every 4 or 6 hours.

Respiratory tract infections

Skin and soft-tissue infections

Intra-abdominal infections

(The usual dose is 3 grams given every 4 hours [18 grams/day] or 4 grams given every 6 hours [16 grams/day] depending on weight and the severity of the infection.)

Infections of the female pelvis and genital tract

Urinary tract infections

Complicated:

150 to 200 mg/kg/day by I.V. infusion in divided doses every 4 or 6 hours. (Usual recommended dosage for average [70 kg] adults: 3 grams q.i.d.)

Uncomplicated:

1 gram I.M. or direct I.V. every 6 hours.

Infections complicated by renal insufficiency*:

Initial loading dose of 3 grams I.V. followed by I.V. doses, based on creatinine clearance and type of dialysis, as indicated below:

Creatinine clearance mL/min.:

over 60

3 grams every 4 hours

30 to 60

2 grams every 4 hours

10 to 30

2 grams every 8 hours

Less than 10

2 grams every 12 hours (or 1 gram I.M. every 6 hours)

less than 10 with hepatic dysfunction

2 grams every 24 hours (or 1 gram I.M. every 12 hours)

patients on peritoneal dialysis

3 grams every 12 hours

patients on hemodialysis

2 grams every 12 hours supplemented with 3 grams after each dialysis

*The half-life of Ticarcillin in patients with renal failure is approximately 13 hours.

Children under 40 kg (88 lbs)

The daily dose for children should not exceed the adult dosage.

Bacterial septicemia

Respiratory tract infections

Skin and soft-tissue infections

Intra-abdominal infections

200 to 300 mg/kg/day by I.V. infusion in divided doses every 4 or 6 hours.

Infections of the female pelvis and genital tract

Urinary tract infections

Complicated:

150 to 200 mg/kg/day by I.V. infusion in divided doses every 4 or 6 hours.

Uncomplicated:

50 to 100 mg/kg/day I.M. or direct I.V. in divided doses every 6 or 8 hours.

Infections complicated by renal insufficiency:

Clinical data are insufficient to recommend an optimum dose.

Children weighing more than 40 kg (88 lbs) should receive adult dosages.

Neonates: In the neonate, for severe infections (sepsis) due to susceptible strains of Pseudomonas, Proteus and E. coli, the following Ticarcillin dosages may be given I.M. or by 10 to 20 minute I.V. infusion:

Infants under 2000 grams body weight:

Infants over 2000 grams body weight:

Aged 0 to 7 days

75 mg/kg/12 hours

(150 mg/kg/day)

Aged 0 to 7 days

75 mg/kg/8 hours

(225 mg/kg/day)

Aged over 7 days

75 mg/kg/8 hours

(225 mg/kg/day)

Aged over 7 days

100 mg/kg/8 hours

(300 mg/kg/day)

This dosage schedule is intended to produce peak serum concentrations of 125 to 150 mcg/mL 1 hour after a dose of Ticarcillin and trough concentrations of 25 to 50 mcg/mL immediately before the next dose.

NOTE: Gentamicin, tobramycin or amikacin may be used concurrently with Ticarcillin for initial therapy until results of culture and susceptibility studies are known.

Seriously ill patients should receive the higher doses. Ticar has proved to be useful in infections in which protective mechanisms are impaired, such as in acute leukemia and during therapy with immunosuppressive or oncolytic drugs.

Directions for use

3 gram Standard Vials

Intramuscular Use

(concentration of approximately 385 mg/mL): For initial reconstitution use Sterile Water for Injection, USP, Sodium Chloride Injection, USP, or 1% Lidocaine Hydrochloride solution‡ (without epinephrine).

Each gram of Ticarcillin should be reconstituted with 2 mL of Sterile Water for Injection, USP, Sodium Chloride Injection, USP, or 1% Lidocaine Hydrochloride solution‡ (without epinephrine) and used promptly. Each 2.6 mL of the resulting solution will then contain 1 gram of Ticarcillin.

‡ For full product information, refer to manufacturer’s package insert for Lidocaine Hydrochloride.

Do not use more than 1 gram of reconstituted Ticarin a single intramuscular injection.As with all intramuscular preparations, Ticar (Ticarcillin disodium) should be injected well within the body of a relatively large muscle using usual techniques and precautions.

Intravenous Administration

(concentration of approximately 200 mg/mL): For initial reconstitution use Sodium Chloride Injection, USP, Dextrose Injection 5% or Lactated Ringer’s Injection.

Reconstitute each gram of Ticarcillin with 4 mL of the appropriate diluent. After the addition of 4 mL of diluent per gram of Ticarcillin, each 1.0 mL of the resulting solution will have an approximate concentration of 200 mg. Once dissolved, further dilute if desired.

Direct Intravenous Injection

In order to avoid vein irritation, administer solution as slowly as possible.

Intravenous Infusion

Administer by continuous or intermittent intravenous drip. Intermittent infusion should be administered over a 30 minute to 2-hour period in equally divided doses.

In order to avoid vein irritation, the solution should be administered as slowly as possible. A dilution of approximately 50 mg/mL or more will further reduce the incidence of vein irritation.

Stability studies in the intravenous solutions listed below indicate that Ticarcillin disodium will provide sufficient activity between 21° and 24°C (70° and 75°F) within the stated time periods at concentrations between 10 mg/mL and 50 mg/mL see Stability Period section below.

After reconstitution and prior to administration Ticar as with other parenteral drugs should be inspected visually for particulate matter and discoloration.

STABILITY PERIOD

Intravenous Solution

Room Temperature

Refrigeration

(concentration of 10 mg/mL to 100 mg/mL)

21° to 24°C (70° to 75°F)

4°C (40°F)

Sodium Chloride Injection, USP

72 hours

14 days

Dextrose Injection 5%

72 hours

14 days

Lactated Ringer’s Injection

48 hours

14 days

Refrigerated solutions stored longer than 72 hours should not be used for multidose purposes.

After reconstitution and dilution to a concentration of 10 mg/mL to 100 mg/mL, this solution can be frozen -18°C (0°F) and stored for up to 30 days. The thawed solution must be used within 24 hours.

Unused solutions should be discarded after the time periods mentioned above.

It is recommended that Ticar and gentamicin sulfate, tobramycin sulfate or amikacin sulfate not be mixed together in the same I.V. solution due to the gradual inactivation of gentamicin sulfate, tobramycin sulfate or amikacin sulfate under these circumstances. The therapeutic effect of Ticar and these aminoglycoside drugs remains unimpaired when administered separately.

How is Ticar Supplied

Ticar (sterile Ticarcillin disodium). Each vial contains Ticarcillin disodium equivalent to 3 grams of Ticarcillin.

NDC 0029-6552-26……………………………………………..3 gram Vial

Store dry powder at room temperature or below.

DATE OF ISSUANCE SEPT. 2002

©2002, GlaxoSmithKline

All rights reserved.

GlaxoSmithKline

Research Triangle Park, NC 27709

TR:L7

Ticar 
Ticarcillin disodium injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0029-6552
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ticarcillin disodium (Ticarcillin) Ticarcillin 3 g
Packaging
# Item Code Package Description
1 NDC:0029-6552-26 1 INJECTION, POWDER, FOR SOLUTION (1 VIAL) in 1 VIAL
Labeler - GlaxoSmithKline
Revised: 01/2006   GlaxoSmithKline

Ticarcillin Pregnancy Warnings

Ticarcillin has not been formally assigned to a pregnancy category by the FDA. Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. No adverse fetal effects have been reported in the literature. Ticarcillin should only be used during pregnancy when need has been clearly established.

Ticarcillin Levels and Effects while Breastfeeding

Summary of Use during Lactation

Ticarcillin is acceptable to use during breastfeeding. Limited information indicates that maternal doses of ticarcillin up to 15 grams daily produce low levels in milk that are not expected to cause adverse effects in breastfed infants. Occasionally, disruption of the infant's gastrointestinal flora, resulting in diarrhea or thrush, has been reported with penicillins, but these effects have not been adequately evaluated.

Drug Levels

Maternal Levels. Only trace levels of ticarcillin were detected for 6 hours after single 1 gram intramuscular doses in 3 women in one study[1][2] and 5 women in another early study.[3]

After ticarcillin doses of 5 grams intravenously three times a day in 10 women, milk levels averaged 2 to 2.5 mg/L. By 12 hours after the last dose, ticarcillin was undetectable in the milk. The total daily intake of a breastfed infant would be negligible.[4]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1. Matsuda S, Tanno M, Kashiwakura T et al. Laboratory and clinical use of ticarcillin. Chemotherapy (Tokyo). 1977;25:2924-31.

2. Matsuda S. Transfer of antibiotics into maternal milk. Biol Res Pregnancy. 1984;5:57-60. PMID: 6743732

3. Cho N, Nakayama T, Uehara K et al. Laboratory and clinical evaluation of ticarcillin in the field of obstetrics and gynecology. Chemotherapy (Tokyo). 1977;25:2911-23.

4. von Kobyletzki D, Dalhoff A, Lindemeyer H et al. Ticarcillin serum and tissue concentrations in gynecology and obstetrics. Infection. 1983;11:144-9. PMID: 6885173

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