Regulatory product record
LINCO-SPECTIN
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Product identity
- Brand name
- LINCO-SPECTIN
- DIN
- 00813893
- DPD drug code
- 10785
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- INTRAMUSCULAR
- Pharmaceutical form(s)
- SOLUTION
- Ingredients
- SPECTINOMYCIN (SPECTINOMYCIN SULFATE) (100 MG), LINCOMYCIN (LINCOMYCIN HYDROCHLORIDE) (50 MG)
- Species (DPD record)
- CATS, DOGS
- Company
- ZOETIS CANADA INC (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 10785
- Archive fingerprint (SHA-256)
- 85cc3ce208af3aa57018c3d14d83f90220c436baef7455384b6d48d9774e1c88
Linked clinical reference
Clinical entries are linked through the active molecule. Check their species, formulation, source and review status separately from this product record.
Clinical evidence
Pending clinical review (PROPOSED)Rule-based (RULE_BASED)— applies to the facts and dose entries in this species selection; individual source records retain their own status.
Indications3
For Oral Use in Swine and Broiler Chickens Only Not for use in layer or breeder chickens Keep Out of Reach of Children INDICATIONS AND USAGE: Swine: Lincomycin Hydrochloride Soluble Powder is indicated for the treatment of swine dysentery (bloody scours). Broiler Chickens: Clostridium perfringens Lincomycin Hydrochloride Soluble Powder is indicated for the control of necrotic enteritis causedbysusceptible to lincomycin.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
SWINE: Directions for Use INDICATIONS AND USAGE : LinxMed-SP Soluble Powder is indicated for the treatment of swine dysentery (bloody scours). DOSAGE AND ADMINISTRATION Dosage: Administer at a dose rate of 250 mg of lincomycin per gallon of drinking water. In clinical studies, this dose rate provided an average of 3.8 mg of lincomycin per pound of body weight per day. Treatment Period: The drug should be administered for a minimum of 5 consecutive days beyond disappearance of symptoms (bloody stools) up to a maximum of 10 consecutive days. If water treatment is discontinued prior to this time, a lincomycin treatment program may be continued with lincomycin premix at 100 grams lincomycin per ton of complete feed as the sole ration according to label directions. Administration: The 40 g packet will medicate 64 gallons of drinking water providing 250 mg/gallon.The 80 g packet will medicate 128 gallons of drinking water providing 250 mg/gallon.The 160 g packet will medicate 256 gallons of drinking water providing 250 mg/gallon.The 480 g packet will medicate 768 gallons of drinking water providing 250 mg/gallon.One scoop (provided) of powder from the 2 lb container will medicate 64 gallons of drinking water providing 250 mg/gallon. A dose of 3.8 mg lincomycin per pound of body weight may be maintained by medicating the drinking water at a concentration of 250 mg per gallon of drinking water when pigs are consuming 1.5 gallons per 100 lbs of body weight per day. Under these circumstances the concentration of lincomycin required in medicated water may be adjusted to compensate for variations in age and weight of animals, the nature and severity of disease symptoms, environmental temperature and humidity, each of which affects water consumption. For use in automatic water proportioners, prepare the stock solution by dissolving the amount of powder indicated (in packets or scoops) below into the number of gallons of water indicated; then adjust the proportioner to deliver 1 ounce of stock solution per gallon of drinking water. NOTE: After a treatment program is discontinued, a control program for swine dysentery may be followed by feeding lincomycin premix at 40 grams lincomycin per ton of complete feed as the sole ration. HONEY BEES: Directions for Use INDICATIONS AND USAGE: LinxMed-SP Soluble Powder is indicated for the control of American foulbrood (Paenibacillus larvae) in honey bees. DOSAGE AND ADMINISTRATION Dosage: Administer 100 mg lincomycin per hive Treatment Period: The drug should be administered to the hive weekly for 3 weeks. Administration: Mix 250 mg LinxMed-SP Soluble Powder (100 mg lincomycin) with 20 g confectioners’/powdered sugar and dust over the tops of the brood chamber. BROILER CHICKENS: Directions for Use INDICATIONS AND USAGE : LinxMed-SP Soluble Powder is indicated for the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin. DOSAGE AND ADMINISTRATION Dosage: Administer at a dose rate of 64 mg of lincomycin per gallon of drinking water. Treatment Period: Start medication as soon as the diagnosis of necrotic enteritis is determined. The drug should be administered for 7 consecutive days. Administration: The 40 g packet will medicate 250 gallons of drinking water providing 64 mg/gallon.The 80 g packet will medicate 500 gallons of drinking water providing 64 mg/gallon.The 160 g packet will medicate 1,000 gallons of drinking water providing 64 mg/gallon.The 480 g packet will medicate 3,000 gallons of drinking water providing 64 mg/gallon.One scoop (provided) of powder from the 2 lb container will medicate 250 gallons of drinking water providing 64 mg/gallon. NOTE: After water medication is discontinued, a recommended control program for necrotic enteritis consists of feeding lincomycin premix at 2 grams lincomycin per ton of complete feed.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
INDICATIONS AND USAGE Mannheimia haemolytica, Pasteurella multocida, Histophilus somni. SpectoGard Sterile Solution is indicated for the treatment of bovine respiratory disease (pneumonia) associated withand
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens7
This calculator performs arithmetic only on the sourced dosing field shown for each result — it does not verify the field's accuracy, does not select which field to use for a patient, and does not replace a veterinarian's order. Not for clinical use. Confirm every result against the primary source before dispensing.
Dose calculation
Species: Species not recorded. Results use the source regimens shown below.
- Review the source route shown below.
- Enter patient weight and its unit.
- For volume, optionally enter a matching label concentration.
Source route: Route not specified
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
- Source regimen: Not available in this source
- Source formulation
- Not specified in this source
- Dose basis
- Not specified in this source
Indication: Not specified in this source field
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
SPL section 34068-7 (DOSAGE & ADMINISTRATION SECTION)
- Source regimen: Not available in this source
- Source formulation
- Not specified in this source
- Dose basis
- Not specified in this source
Indication: Not specified in this source field
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
SPL section 34068-7 (DOSAGE & ADMINISTRATION SECTION)
- Source regimen: Not available in this source
- Source formulation
- Not specified in this source
- Dose basis
- Not specified in this source
Indication: Not specified in this source field
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
SPL section 34068-7 (DOSAGE & ADMINISTRATION SECTION)
- Source regimen: Not available in this source
- Source formulation
- Not specified in this source
- Dose basis
- Not specified in this source
Indication: Not specified in this source field
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
SPL section 34068-7 (DOSAGE & ADMINISTRATION SECTION)
- Source regimen: Not available in this source
- Source formulation
- Not specified in this source
- Dose basis
- Not specified in this source
Indication: Not specified in this source field
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
SPL section 34068-7 (DOSAGE & ADMINISTRATION SECTION)
- Source regimen: Not available in this source
- Source formulation
- Not specified in this source
- Dose basis
- Not specified in this source
Indication: Not specified in this source field
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
SPL section 34068-7 (DOSAGE & ADMINISTRATION SECTION)
- Source regimen: Not available in this source
- Source formulation
- Not specified in this source
- Dose basis
- Not specified in this source
Indication: Not specified in this source field
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
SPL section 34068-7 (DOSAGE & ADMINISTRATION SECTION)
Adverse effects161
To report suspected adverse drug events, for technical assistance orto obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma,Inc. at 1-877-994-4883 or www.huvepharma.us. For additionalinformation about adverse drug experience reporting for animal drugs,contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
ADVERSE REACTIONS The use of SpectoGard (spectinomycin sulfate) Sterile Solution may result in mild swelling at the injection site.Anaphylactic reactions may occur in animals previously sensitized.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Death6 reports
- Depression6 reports
- Vomiting6 reports
- Bradycardia5 reports
- Lack of efficacy (bacteria) - NOS4 reports
- Abdominal pain3 reports
- Anorexia3 reports
- Fever3 reports
- Lack of efficacy - NOS3 reports
- Polydipsia3 reports
- Anaphylaxis2 reports
- Ataxia2 reports
Cat
- Weakness4 reports
- Anaemia NOS3 reports
- Death3 reports
- Dehydration3 reports
- Not eating3 reports
- Sleepiness - systemic disorder3 reports
- Wobbliness3 reports
- Application site abscess2 reports
- Application site burn2 reports
- Diarrhoea2 reports
- Low platelet count2 reports
- Nasal bleeding2 reports
Contraindications1
CONTRAINDICATIONS AS with all drugs, the use of SpectoGard Sterile Solution is contraindicated in animals previously found to be hypersensitive to the drug.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Precautions9
Discard medicated drinking water daily and replace with fresh medicated drinking water.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Not for human use.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34071-1 (WARNINGS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
PRECAUTIONS: Swine: Chickens: Discard medicated drinking water if not used within 2 days. Fresh stock solution should be prepareddaily. Do not use the water treatment and the feed treatment simultaneously. Do not allow rabbits,hamsters, guinea pigs, horses, or ruminants access to water containing lincomycin. Ingestion by thesespecies may result in severe gastrointestinal effects.If clinical signs of bloody scours (watery, mucoid or bloody stools) have not improved during thefirst 6 days of medication, discontinue treatment and redetermine the diagnosis. Occasionally, swine fedlincomycin may within the first 2 days after the onset of treatment develop diarrhea and/or swelling of theanus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. Theseconditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment.The safety of lincomycin has not been demonstrated for pregnant swine or swine intended for breeding.Not for use in layer and breeder chickens.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
PRECAUTIONS: Swine: Chickens: Discard medicated drinking water if not used within 2 days. Fresh stock solution should be prepared daily. Do not use the watertreatment and the feed treatment simultaneously. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to watercontaining lincomycin. Ingestion by these species may result in severe gastrointestinal effects.If clinical signs of bloody scours (watery, mucoid or bloody stools) have not improved during the first 6 days of medication,discontinue treatment and redetermine the diagnosis. Occasionally, swine fed lincomycin may within the first 2 days after the onset oftreatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritablebehavior. These conditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment. The safety oflincomycin has not been demonstrated for pregnant swine or swine intended for breeding.Not for use in layer and breeder chickens.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics1
CLINICAL PHARMACOLOGY Microbiology Spectinomycin is bacteriostatic and exerts its antibacterial effect by binding to the 30S ribosome and inhibiting bacterial protein synthesis. Spectinomycin has activity against a variety of gram-negative bacteria, some mycoplasma, and a limited number of gram-positive bacteria. Generally, it is not active against anaerobic bacteria. in vitro in vivo Mannheimia haemolytica, Pasteurella multocida, Histophilus somni Spectinomycin has demonstratedandactivity against the three major pathogenic bacteria (and) associated with bovine respiratory disease (pneumonia). in vitro Actinomyces pyogenes, Mycoplasma bovis, Mycoplasma dispar in vitro Spectinomycin has also demonstratedactivity againstand. The clinical significance of thisactivity in cattle has not been demonstrated.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34090-1 (CLINICAL PHARMACOLOGY SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Literature references26
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- Evaluating efficacy of oxytetracycline, lincomycin, and tylosin for treatment of clinical European foulbrood disease.
Study summary not available in the imported record. Open the original citation to review the study.
- Comparative validation of LC-MS, micro-bioassay, and ELISA for lincomycin quantification: application to pharmacokinetic analysis in healthy and co-infected porcine models.
Study summary not available in the imported record. Open the original citation to review the study.
- Prevalence and antimicrobial resistance of Lactococcus petauri, L. formosensis, and L. garvieae in retail fish, Japan: A pilot study for antimicrobial resistance monitoring of gram-positive bacteria in seafoods.
Study summary not available in the imported record. Open the original citation to review the study.
- Identification and detection of genetic markers associated with antimicrobial susceptibility and evaluation of efflux pump mechanisms in Mycoplasma iowae.
Study summary not available in the imported record. Open the original citation to review the study.
- Probiotics and enzymes in weaned piglets' diets can lower belly nosing frequency and improve performance and nitrogen balance.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: DailyMed, U.S. National Library of Medicine; PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration.